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Proprietary Magnetic Resonance Imaging (MRI) of the Breast - Medical Clinical Policy Bulletins | A... P (https://www.aetna.com/) Magnetic Resonance Imaging (MRI) of the Breast Policy History Last Review 03/23/2020 Effective: 03/22/1996 Next Review: 01/28/2021 Review History Definitions Additional Information Clinical Policy Bulletin Notes Number: 0105 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. I. Aetna considers magnetic resonance imaging (MRI), with or without contrast materials, of the breast medically necessary for members who have had a recent (within the past year) conventional mammogram and/or breast sonogram, in any of the following circumstances where MRI of the breast may affect their clinical management: A. For individuals who received radiation treatment to the chest between ages 10 and 30 years, such as for Hodgkin disease, Wilm's tumors; or B. To assess tumor location, size, and extent before and/or after neoadjuvant chemotherapy in persons with locally advanced breast cancer, for determination of eligibility for breast conservation therapy; or C. To detect implant rupture in symptomatic members; or D. To detect suspected local tumor recurrence in members with breast cancer who have undergone age 1 of 61
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0105 Magnetic Resonance Imaging (MRI) of the Breast · I. Aetna considers magnetic resonance imaging (MRI), with or without contrast materials, of the breast medically necessary for

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Page 1: 0105 Magnetic Resonance Imaging (MRI) of the Breast · I. Aetna considers magnetic resonance imaging (MRI), with or without contrast materials, of the breast medically necessary for

Proprietary

Magnetic Resonance Imaging (MRI) of the Breast - Medical Clinical Policy Bulletins | A... P

(https://www.aetna.com/)

Magnetic Resonance Imaging(MRI) of the Breast

Policy History

Last Review

03/23/2020

Effective: 03/22/1996

Next

Review: 01/28/2021

Review History

Definitions

Ad d i t ion al Information

Clinical Policy Bulletin

Notes

Number: 0105

Policy *Please see amendment for Pennsylvania Medicaid

at the end of this CPB.

I. Aetna considers magnetic resonance imaging (MRI), with

or without contrast materials, of the breast medically

necessary for members who have had a recent (within

the past year) conventional mammogram and/or breast

sonogram, in any of the following circumstances where

MRI of the breast may affect their clinical management:

A. For individuals who received radiation treatment to

the chest between ages 10 and 30 years, such as for

Hodgkin disease, Wilm's tumors; or

B. To assess tumor location, size, and extent before

and/or after neoadjuvant chemotherapy in persons

with locally advanced breast cancer, for

determination of eligibility for breast conservation

therapy; or

C. To detect implant rupture in symptomatic members;

or

D. To detect suspected local tumor recurrence in

members with breast cancer who have undergone

age 1 of 61

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mastectomy and breast reconstruction with an

implant; or

E. To detect local tumor recurrence in individuals with

breast cancer who have radiographically dense

breasts or old scar tissue from previous breast

surgery that compromises the ability of combined

mammography and ultrasonography; or

F. To detect the extent of residual cancer in the

recently post-operative breast with positive

pathological margins after incomplete lumpectomy

when the member still desires breast conservation

and local re-excision is planned; or

G. To evaluate persons with lobular carcinoma in situ

(LCIS), ductal carcinoma in situ (DCIS) or atypical

ductal hyperplasia (ADH); or

H. To guide localization of breast lesions to perform

needle biopsy when suspicious lesions exclusively

detected by contrast-enhanced MRI can not be

visualized with mammography or ultrasonography;

or

I. To localize the site of primary occult breast cancer in

individuals with adenocarcinoma suggestive of

breast cancer discovered as axillary node metastasis

or distant metastasis without focal findings on

physical examination or on

mammography/ultrasonography; or

J. To map the extent of primary tumors and identify

multi-centric disease in persons with localized breast

cancer (stage I or II, T0-1 N0-1 M0) prior to surgery

(lumpectomy versus mastectomy); or

K. Contralateral breast examination for members with

current breast malignancy; or

L. Lesion characterization (nipple retraction, Unilateral

drainage from the nipple that is bloody or clear)

when all other imaging examinations, such as

ultrasound and mammography, and physical

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examination are inconclusive for the presence of

breast cancer; or

M. After breast conservation therapy in women who

exhibit suspicious clinical or imaging findings that

remain indeterminate after complete

mammographic and sonographic evaluations

II. Aetna considers breast MRI a medically necessary

adjunct to mammography for screening of women

considered to be at high genetic risk of breast cancer

because of any of the following:

A. Carry or have a first-degree relative who carries a

genetic mutation in the TP53 or PTEN genes (Li-

Fraumeni syndrome and Cowden and Bannayan­

Riley-Ruvalcaba syndromes); or

B. Confirmed presence of BRCA1 or BRCA2 mutation; or

C. First degree blood relative with BRCA1 or BRCA2

mutation and are untested; or

D. Have a lifetime risk of breast cancer of 20 to 25 % or

more using standard risk assessment models

(BRCAPRO, Claus model, Gail model, or Tyrer-Cuzick).

III. Aetna considers breast MRI medically necessary to

detect intra-capsular (silent) rupture of silicone gel-filled

breast implants. Screening for silent intra-capsular

rupture more frequently than every 2 years is not

considered medically necessary.

IV. Aetna considers breast MRI experimental and

investigational for all other indications, including any of

the following, because there is insufficient scientific

evidence to support its use:

A. Dermatomyositis as an indication for use of MRI for

breast cancer screening; or

B. Quantitative measurements of breast density; or

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C. Surveillance of asymptomatic individuals with breast

cancer or carcinoma in situ who have completed

primary therapy and who are not at high genetic risk

of breast cancer; or

D. To confirm implant rupture in symptomatic

individuals whose ultrasonography shows rupture,

especially with implants more than 10 years old

(ultrasound sufficient to proceed with removal); or

E. To diagnose fat necrosis post-breast reduction

surgery; or

F. To differentiate benign from malignant breast

disease, especially clustered micro-calcifications; or

G. To differentiate cysts from solid lesions (ultrasound

indicated); or

H. To evaluate breasts before biopsy in an effort to reduce

the number of surgical biopsies for benign lesions; or

I. To evaluate suspicious (BI-RADS 4 or 5) lesions found

on mammogram and/or ultrasound. (A lesion

categorized as have BI-RADS 4 or 5 should be

biopsied.); or

J. To evaluate retro-pectoral fat grafting in breast

reduction; or

K. To provide an early prediction of response to adjuvant

breast cancer chemotherapy in guiding choice of

chemotherapy regimen; or

L. To screen for breast cancer in members with average

risk of breast cancer; or

M. To screen BRCA-positive men.

V. Note : Aetna considers computer-aided detection of

malignancy integral to MRI of the breast and not

separately reimbursed.

VI. Aetna considers post-surgical intra-operative breast MRI

for quantifying tumor deformation and detecting

residual breast cancer experimental and investigational

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because its clinical value has not been established.

VII. Aetna considers quantitative breast MRI for predicting

the risk of breast cancer recurrence experimental and

investigational because its clinical value has not been

established.

See also CPB 0584 - Mammography (../500_599/0584.html).

Background

Mammography is the only screening test proven to lower

breast cancer morbidity and mortality. Although

mammography is an effective screening tool, it does have

limitations, especially in women with dense breasts. New

imaging techniques are being developed to overcome these

limitations, enhance cancer detection, and improve patient

outcome. Digital mammography, computer-aided detection

(CAD), breast ultrasound, and breast magnetic resonance

imaging (MRI) are frequently used adjuncts to mammography

in today's clinical practice.

An expert panel convened by the American Cancer Society

recommended the use of MRI for screening women at a 20 to

25 % or greater lifetime risk for breast cancer (Saslow et al,

2007). The panel states that, in addition to mammography,

annual screening using MRI is recommended for women who:

▪ Carry or have a first-degree relative who carries a genetic

mutation in the TP53 or PTEN genes (Li-Fraumeni

syndrome and Cowden and Bannayan-Riley-Ruvalcaba

syndromes)

▪ Have a BRCA 1 or 2 mutation

▪ Have a first-degree relative with a BRCA 1 or 2 mutation and are untested

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▪ Have a lifetime risk of breast cancer of 20 to 25 % or more

using standard risk assessment models

▪ Received radiation treatment to the chest between ages 10

and 30, such as for Hodgkin Disease

The ACS guidelines recommend use of MRI in addition to, not

in place of, mammography for screening high-risk women

(Saslow et al, 2007). The guidelines explain that all of the

clinical trials screened participants with both MRI and

mammography at the same time. The guidelines state that

there is no evidence to support one approach over the other.

"For the majority of women at high risk, it is critical that MRI

screening be provided in addition to, not instead of,

mammography, as the sensitivity and cancer yield of MRI and

mammography combined is greater than for MRI alone."

The guideline provides information about 3 risk assessment

models available for calculating breast cancer risk

(BRCAPRO, Claus model, and Tyrer-Cuzick). Software for

each model is available online (see Appendix below). The 3

risk models utilize different combinations of risk factors, are

derived from different data sets, and vary in the age to which

they calculate cumulative breast cancer risk. As a result, they

may generate different risk estimates for a given patient. This

variability is an indicator that the risk models provide

approximate, rather than precise, estimates of breast cancer

risk. According to ACS guidelines, each of the risk models can

be used for the purpose of identifying patients who would

benefit from breast MRI screening (Saslow et al, 2007). In

addition, the Gail model is widely used in research studies and

clinical counseling to predict a woman's lifetime risk of

developing breast cancer. Calculation of a 5-year and lifetime

breast cancer risk according to the Gail model can be

performed by accessing the National Cancer

Institute's website and searching for information on breast

cancer risk.

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The ACS panel also identified several risk subgroups for which

the available data are insufficient to recommend either for or

against MRI screening (Saslow et al, 2007). They include

women with a personal history of breast cancer, carcinoma in

situ, atypical hyperplasia, and extremely dense breasts on

mammography.

Although ultrasound is sufficient to confirm rupture of breast

implants in women with symptoms, MRI may be necessary to

detect intra-capsular rupture of silicone gel-filled breast

implants in asymptomatic women. The sensitivity of plastic

surgeons familiar with implants to diagnose rupture is 30 %

compared to 89 % for MRI (Holmich et al, 2005). The FDA

therefore recommends that women with silicone gel-filled

breast implants have regular breast MRIs over their lifetime to

screen for silent rupture. The FDA-approved labeling of

silicone gel-filled breast implants recommends that the first

MRI be performed 3 years post-operatively, then every 2 years

thereafter. The FDA recommends that the MRI have at least a

1.5 Tesla magnet, a dedicated breast coil, and a radiologist

experienced with breast implant MRI films for signs of rupture.

Houssami et al (2008) reviewed the evidence on MRI in

staging the affected breast to determine its accuracy and

impact on treatment. These researchers estimated summary

receiver operating characteristic curves, positive predictive

value (PPV), true-positive (TP) to false-positive (FP) ratio, and

examined their variability according to quality criteria. Pooled

estimates of the proportion of women whose surgery was

altered were calculated. Data from 19 studies showed MRI

detects additional disease in 16 % of women with breast

cancer (n = 2,610). Magnetic resonance imaging incremental

accuracy differed according to the reference standard (RS; p =

0.016) decreasing from 99 % to 86 % as the quality of the RS

increased. Positive predictive value was 66 % (95 %

confidence interval [CI]: 52 % to 77 %) and TP:FP ratio was

1.91 (95 % CI: 1.09 to 3.34). Conversion from wide local

excision (WLE) to mastectomy was 8.1 % (95 % CI: 5.9 to

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11.3), from WLE to more extensive surgery was 11.3 % in multi-

focal/multi-centric disease (95 % CI: 6.8 to 18.3). Due to MRI-

detected lesions (in women who did not have additional

malignancy on histology) conversion from WLE to mastectomy

was 1.1 % (95 % CI: 0.3 to 3.6) and from WLE to more

extensive surgery was 5.5 % (95 % CI: 3.1 to 9.5). The

authors concluded that MRI staging causes more extensive

breast surgery in an important proportion of women by

identifying additional cancer, however there is a need to

reduce FP MRI detection. They stated that randomized trials

are needed to determine the clinical value of detecting

additional disease which changes surgical treatment in women

with apparently localized breast cancer.

In a review on the utility of MRI for the screening and staging

of breast cancer, Patani and Mokbel (2008) stated that while

MRI can facilitate local staging, especially the evaluation of

ipsilateral multi-centric or multi-focal lesions as well as

synchronous contralateral disease that may be missed by

conventional imaging; however, efficacy with respect to

clinically relevant and patient oriented end-points has yet to be

addressed in the context of clinical trials.

Computer-aided detection has been used to aid radiologists’

interpretation of contrast-enhanced MRI of the breast, which is

sometimes used as an alternative to mammography or other

screening and diagnostic tests because of its high sensitivity in

detecting breast lesions, even among those in whom

mammography is less accurate (e.g., younger women and

those with denser breasts). However, MRI has a high FP rate

because of the difficulty in differentiating between benign and

malignant lesions. The use of CAD may also reduce the time

needed to interpret breast MRI images, which currently takes

much longer than reading mammograms.

The BlueCross and BlueShield Association’s Technology

Evaluation Center (TEC) Medical Advisory Panel (2006)

assessed the evidence on the use of CAD with MRI of the

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breast by comparing the sensitivity, specificity, and recall rate

(percentage of patients asked to come back for further

evaluation) of MRI with and without the use of commercially

available CAD systems in detecting malignant lesions,

evaluating the extent of disease in women with cancer, or

gauging the impact of treatment. According to this

assessment, many of the studies on the use of CAD with MRI

of the breast mainly reported on the development of CAD

systems, or testing new CAD approaches. The assessment

noted that few of them evaluated commercially available CAD

systems. Several of those that did, reported on the

development and testing of approaches that underlie one of

the commercially available systems (3TP); the assessment

stated that it is not clear to whatdegree the current 3TP

system has or has not been modified compared to these

earlier approaches. Although the studies had to have

separate testing data sets to be included in the TEC

assessment, these data sets often were enriched with more

cancer cases or consisted exclusively of cases in which

lesions had been found. The TEC assessment found, as a

result, the range of sensitivities and specificities cannot be

applied to the populations usually found in a clinical setting.

The TEC assessment also found that many of the studies of

CAD systems were retrospective, and reported primarily on

their development and testing; thus, these studies lacked the

rigor and generalizability of a large, prospective, well-designed

study.

The TEC assessment stated that the literature is unclear on

how CAD systems are to be used. In the case of CAD with

mammography, the radiologist reads the original films first,

makes a diagnosis, and then reviews the CAD results. The

TEC assessment explained that, because CAD is not 100 %

sensitive, lesions detected by mammography both before the

use of CAD and after viewing the CAD results may be worked

up. Thus, CAD can add to the sensitivity of mammography,

but not its specificity. The TEC assessment noted, however,

with MRI of the breast, the sensitivity is already high, and the

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focus is mainly on enhancing the specificity. In some studies,

it appears that CAD was intended as an adjunct to the initial

MRI reading, just as with CAD and mammography. In other

studies, it was proposed as a way of speeding up the MRI

reading process, and the precise protocol to be followed in

reading the MRI images is unclear. In addition, unlike in the

case of CAD with mammography, in the documents regarding

the FDA clearance it did not specify that CAD must be added

only after an initial reading of the images alone, although it did

say for one system that “patient management decisions should

not be made based solely on the results of the CADstream

analysis”. The TEC assessment observed that the impact of

CAD on the accuracy of MRI of the breast may depend partly

on how the CAD results are incorporated into the reading and

diagnostic process.

Based on the available evidence, the Blue Cross and Blue

Shield Association Medical Advisory Panel concluded that

there is insufficient evidence to evaluate if the use of CAD

systems would maintain or increase the sensitivity, specificity,

and recall rates of MRI of the breast. The TEC assessment

concluded that, given the inability to evaluate these

intermediate outcomes, it is impossible to evaluate the impact

of CAD on health outcomes such as treatment success and

survival of patients with breast cancer.

There is limited evidence on the predictive value of

preoperative MRI in persons who are newly diagnosed with

early stage breast cancer, and no consistent evidence that a

pre-operative breast MRI confers a benefit to the patient by

improving clinical outcomes or surgical procedures. Lehman

et al (2009) stated that use of breast MRI in the pre-operative

evaluation of patients recently diagnosed with breast cancer

has increased significantly over the past 10 years because of

its well-documented high sensitivity for detecting otherwise

occult breast cancer in the affected and contralateral breasts.

However, published research reports on the impact of this

improved cancer detection are limited. Equally important are

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growing concerns that the quality of breast MRI may vary

significantly across practice sites, and therefore the published

value of MRI may not be achieved for many patients. These

researchers described the peer-reviewed, published clinical

research trials evaluating breast MRI in patients with newly

diagnosed breast cancer on which the National

Comprehensive Cancer Network (NCCN) practice guidelines

on breast cancer were based. The current NCCN guidelines

(2011) recommend that breast MRI be considered for patients

with a newly diagnosed breast cancer to evaluate the extent of

cancer or presence of multi-focal or multi-centric cancer in the

ipsilateral breast; and for screening of the contralateral breast

cancer at the time of initial diagnosis (category 2B).

Lehman and colleagues (2007) conducted a study to examine

if MRI could improve on clinical breast examination and

mammography in detecting contralateral breast cancer soon

after the initial diagnosis of unilateral breast cancer. A total of

969 women with a recent diagnosis of unilateral breast cancer

and no abnormalities on mammographic and clinical

examination of the contralateral breast underwent breast MRI.

The diagnosis of MRI-detected cancer was confirmed by

means of biopsy within 12 months after study entry. The

absence of breast cancer was determined by means of biopsy,

the absence of positive findings on repeat imaging and clinical

examination, or both at 1 year of follow-up. MRI detected

clinically and mammographically occult breast cancer in the

contralateral breast in 30 of 969 women who were enrolled in

the study (3.1 %). The sensitivity of MRI in the contralateral

breast was 91 %, and the specificity was 88 %. The negative

predictive value of MRI was 99 %. A biopsy was performed on

the basis of a positive MRI finding in 121 of the 969 women

(12.5 %), 30 of whom had specimens that were positive for

cancer (24.8 %); 18 of the 30 specimens were positive for

invasive cancer. The mean diameter of the invasive tumors

detected was 10.9 mm. The additional number of cancers

detected was not influenced by breast density, menopausal

status, or the histologic features of the primary tumor. The

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authors concluded that MRI can detect cancer in the

contralateral breast that is missed by mammography and

clinical examination at the time of the initial breast-cancer

diagnosis.

Bernard and associates (2010) evaluated the prevalence of

synchronous, occult contralateral breast cancer detected by

MRI but not by mammography or clinical breast examination in

women with newly diagnosed breast cancer, including those

aged 70 years or older. These investigators reviewed MRI

results for women with newly diagnosed breast cancer who

underwent bilateral breast MRI after negative mammography

and clinical examination. The prevalence of pathologically

confirmed contralateral carcinoma diagnosed solely by MRI

was determined and analyzed in the context of age, breast

density, family history, menopausal status, and primary-tumor

characteristics. Logistic regression was used to explore the

association between contralateral carcinoma and potential

patient risk factors. A total of 425 women were evaluated, of

whom 129 (30 %) were aged 70 years or older. A

contralateral biopsy was recommended and performed solely

on the basis of MRI in 72 of the 425 women (17 %). Sixteen of

these 72 women (22 %) had pathologically confirmed

carcinoma, including 7 in the older subgroup. The prevalence

of clinically and mammographically occult contralateral

carcinoma detected by MRI was 3.8 % (16/425) overall and

5.4 % (7/129) in the group of older women. When potential

risk factors for contralateral breast cancer were evaluated,

post-menopausal status was the only significant predictor of

contralateral cancer detected by MRI (p = 0.016). The

authors concluded that contralateral breast screening with MRI

should be considered in post-menopausal women w ith newly

diagnosed breast cancer, even those aged 70 years or older at

diagnosis.

On the other hand, Houssami and Hayes (2009) noted that

randomized controlled trials (RCTs) have shown equiva lent

survival for women with early stage breast cancer who are

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treated with breast-conservation therapy (local excision and

radiotherapy) or mastectomy. Decades of experience

have shown that breast-conservation therapy provides

excellent local control based on defined standards of care.

Magnetic resonance imaging has been introduced in pre-

operative staging of the affected breast in women with newly

diagnosed breast cancer because it detects additional foci of

cancer that are occult on conventional imaging. The median

incremental (additional) detection for MRI has been estimated

as 16 % in meta-analysis. In the absence of consensus on the

role of pre-operative MRI, these investigators reviewed data

on its detection capability and its impact on treatment. They

outlined that the assumptions behind the adoption of MRI,

namely that it will improve surgical planning and will lead to a

reduction in re-excision surgery and in local recurrences, have

not been substantiated by trials. Evidence consistently shows

that MRI changes surgical management, usually from breast

conservation to more radical surgery; however, there is no

evidence that it improves surgical care or prognosis.

Emerging data indicate that MRI does not reduce re-excision

rates and that it causes FPs in terms of detection and

unnecessary surgery; overall there is little high-quality

evidence at present to support the routine use of pre-operative

MRI. The authors concluded that RCTs are needed to

establish the clinical, psychosocial, and long-term effects of

MRI and to show a related change in treatment from standard

care in women newly affected by breast cancer.

Furthermoer, Solin (2010) stated that for the woman with a

newly diagnosed early stage breast cancer, the routine use of

pre-operative breast MRI is not indicated beyond conventional

breast imaging (i.e., mammography with correlation ultrasound

as indicated). There is no consistent evidence that a pre-

operative breast MRI confers a benefit to the patient by

improving clinical outcomes or surgical procedures. In a meta-

analysis of studies reporting on the use of pre-operative breast

MRI for the patient with an established index cancer, multi-

focal or multi-centric disease was found on breast MRI in 16 %

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of the patients, a rate substantially higher than the rate of local

recurrence after breast conserving surgery plus definitive

radiation treatment. In the largest retrospective study of

patients treated with breast conserving surgery plus radiation,

no gain was found for adding a breast MRI to conventional

breast imaging. No randomized clinical trial has been

designed to evaluate long-term clinical outcomes associated

with adding a pre-operative breast MRI. Adding pre-operative

breast MRI can alter clinical management in ways that are

potentially harmful to patients (e.g., increased ipsilateral

mastectomies, increased contralateral prophylactic

mastectomies, increased work-ups, and delay to definitive

surgery). The authors concluded that the routine use of pre-

operative breast MRI is not warranted for the typical patient

with a newly diagnosed early stage breast cancer.

There are no clinical studies of breast MRI in BRCA-positive

men. Neither the American Cancer Society guidelines nor the

National Comprehensive Cancer Network (NCCN) guidelines

recommend breast MRI screening for men.

Wurdinger et al (2005) evaluated the MRI appearance of

phyllodes breast tumors and to differentiate them from fibro-

adenomas. MR images were obtained on a 1.5-T imager. T1-

and T2-weighted sequences and dynamic 2D fast-field echo

T1-weighted sequences were performed. MR images of 23

patients with 24 phyllodes breast tumors (1 malignant, 23

benign) were analyzed with respect to morphology and

contrast enhancement. The tumors were compared with the

MRI appearance of 81 fibro-adenomas of 75 patients. Well-

defined margins were seen in 87.5 % of the phyllodes tumors

and 70.4 % of the fibro-adenomas, and a round or lobulated

shape in 100 % and 90.1 %, respectively. A heterogeneous

internal structure was observed in 70.8 % of phyllodes tumors

and in 49.4 % of fibro-adenomas. Non-enhancing internal

septations were found in 45.8 % of phyllodes tumors and 27.2

% of fibro-adenomas. A significantly greater increase in signal

was seen on T2-weighted images in the tissue surrounding

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phyllodes tumors (21 %) compared with fibro-adenomas (1.2

%). Most of both lesions appeared with low signal intensity on

T1- and T2-weighted images. After the administration of

contrast material, 33.3 % of phyllodes tumors and 22.2 % of

fibro-adenomas showed a suspicious signal intensity-time

course. The authors concluded that phyllodes breast tumors

and other fibro-adenomas can not be precisely differentiated

on breast MRI. Phyllodes tumors have benign morphologic

features and contrast enhancement characteristics suggestive

of malignancy in 33 % of cases.

Biondi et al (2009) stated that phyllodes tumors are unusual

biphasic fibro-epithelial neoplasms of the breast, accounting

for less than 1 % of all breast tumors and raising issues of

diagnosis and therapeutic choice. They can grow quickly and

when the maximum diameter is greater than 10 cm, they are

known as giant phyllodes tumors. Ultrasound, mammography

and fine needle aspiration are not effective. A potentially

useful diagnostic modality is MRI. Core tissue biopsy or

incisional biopsy represent the preferred means of pre-

operative diagnosis. Conservative treatment can be effective

also in giant tumors depending upon the size of the tumor and

the breast if a complete excision with an adequate margin of

normal breast tissue can be achieved, so avoiding local

recurrence often accompanied by worse histopathology. The

authors reported the case of a giant benign phyllode tumor of

the breast treated with conservative surgery, quadrantectomy

and oncoplasty. No local recurrence at 4 years follow-up.

An UpToDate review on "Phyllodes tumors of the

breast" (Grau et al, 2011) states that the role of MRI in the

diagnosis and management of phyllodes tumors is not clear.

A retrospective study of 30 patients with biopsy confirmed

phyllodes tumors showed that malignant phyllodes tumors are

seen as well-circumscribed tumors with irregular walls, high

signal intensity on T1-weighted images and low signal intensity

on T2-weighted images. Cystic change may be seen as well.

Interestingly, a rapid enhancement pattern is seen more

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commonly with benign rather than malignant phyllodes tumors,

which is the opposite of the pattern seen with

adenocarcinomas of the breast. When the diagnosis of a

phyllodes tumor has been made on core biopsy, breast MRI

may prove helpful in determining the extent of disease and

facilitating pre-operative planning. However, the use of breast

MRI in surgical planning for phyllodes tumors is controversial

as there are very little data on its role in this setting as they are

so rare.

Furthermore, the NCCN Clinical Practice Guideline on breast

cancer (2011) mentions the use of ultrasonography and

mammography for the work-up of patients with phyllodes

tumor; but does not mention the use of MRI in the

management of these patients.

In a retrospective cohort study, Weber and colleagues (2012)

examined the effect of pre-operative MRI on the reoperation

rate in women with operable breast cancer. Women with

operable breast cancer treated by a single surgeon between

January 1, 2006, and December 31, 2010 were included in this

study; selective pre-operative MRI based on breast density

and histologic findings were carried out. Main outcome

measures were reoperation rate and pathologically avoidable

mastectomy at initial operation. Of 313 patients in the study,

120 underwent pre-operative MRI. Patients undergoing MRI

were younger (mean age, 53.6 versus 59.5 years; p < 0.001),

were more often of non-Hispanic white race/ethnicity (61.7 %

versus 52.3 %, p < 0.05), and more likely had heterogeneously

dense or very dense breasts (68.4 % versus 22.3 %, p <

0.001). The incidence of lobular carcinoma (8.3 % in the MRI

group versus 5.2 % in the no MRI group, p = 0.27) and the

type of surgery performed (mastectomy versus partial

mastectomy, p = 0.67) were similar in both groups. The mean

pathological size of the index tumor in the MR imaging group

was larger than that in the no MRI group (2.02 versus 1.72 cm,

p = 0.009), but the extent of disease was comparable (75.8 %

in the MR imaging group versus 82.9 % in the no MRI group

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had pathologically localized disease, p = 0.26). The

reoperation rate was similar between the 2 groups (19.1 % in

the MRI group versus 17.6 % in the no MRI group,p = 0.91)

even when stratified by breast density (p = 0.76), pT2 tumor

size (p = 0.35), or lobular carcinoma histologic findings (p =

0.26). Pathologically avoidable mastectomy (multi-focal or multi-

centric MRI and uni-focal histopathological findings) was

observed in 12 of 47 patients (25.5 %) with pre-operative MRI

who underwent mastectomy. The authors concluded that the

selective use of pre-operative MRI to decrease reoperation in

women with breast cancer is not supported by these data. In a

considerable number of patients, MRI over-estimated the

extent of disease.

Plana et al (2012) estimated the diagnostic accuracy of MRI in

detecting additional lesions and contralateral cancer not

identified using conventional imaging in primary breast

cancer. These investigators conducted a systematic review

and meta-analyses to estimate diagnostic accuracy indices

and the impact of MRI on surgical management. A total of 50

articles were included (n = 10,811 women).MRIdetected

additional disease in 20 % of women and in the contralateral

breast in 5.5 %. The summary PPV of ipsilateral additional

disease was 67 % (95 % CI: 59 to 74 %). For contralateral

breast, the PPV was 37 % (95 % CI: 27 to 47 %). For

ipsilateral lesions, MRI devices greater than or equal to 1.5

Tesla (T) had higher PPV (75 %, 95 % CI: 64 to 83 %) than

MRI with less than 1.5 T (59 %, 95 % CI: 53 to 71 %). Similar

results were found for contralateral cancer, PPV 40 % (95 %

CI: 29 to 53 %) and 19 % (95 % CI: 8 to 39 %) for high- and

low-field equipments, respectively. True-positive MRI findings

prompted conversion from wide local excision (WLE) to more

extensive surgery in 12.8 % of women while in 6.3 % this

conversion was inappropriate. The authors concluded that

MRI shows high diagnostic accuracy, but MRI findings should

be pathologically verified because of the high FP rate. They

stated that future research on this emerging technology should

focus on patient outcome as the primary end-point.

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Prevos et al (2012) examined if MRI can identify pre-treatment

differences or monitor early response in breast cancer patients

receiving neoadjuvant chemotherapy. PubMed, Cochrane

library, Medline and Embase databases were searched for

publications until January 1, 2012. After primary selection,

studies were selected based on pre-defined

inclusion/exclusion criteria. Two reviewers assessed study

contents using an extraction form. In 15 studies, which were

mainly under-powered and of heterogeneous study design, 31

different parameters were studied. Most frequently studied

parameters were tumor diameter or volume, K(trans), K(ep), V

(e), and apparent diffusion coefficient (ADC). Other

parameters were analyzed in only 2 or less studies. Tumor

diameter, volume, and kinetic parameters did not show any pre-

treatment differences between responders and non-

responders. In 2 studies, pre-treatment differences in ADC

were observed between study groups. At early response

monitoring significant and non-significant changes for all

parameters were observed for most of the imaging

parameters. The authors concluded that evidence on

distinguishing responders and non-responders to neoadjuvant

chemotherapy using pre-treatment MRI, as well as using MRI

for early response monitoring, is weak and based on under-

powered study results and heterogeneous study design.

Thus, the value of breast MRI for response evaluation has not

yet been established.

The American Society of Clinical Oncology’s clinical practice

guideline update on “Breast cancer follow-up and

management after primary treatment” (Khatcheressian et al,

2013) provided recommendations on the follow-up and

management of patients with breast cancer who have

completed primary therapy with curative intent. A systematic

review of the literature published from March 2006 through

March 2012 was completed using Medline and the Cochrane

Collaboration Library. An Update Committee reviewed the

evidence to determine whether the recommendations were in

need of updating. There were 14 new publications that met

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inclusion criteria: 9 systematic reviews (3 included meta-

analyses) and 5 RCTs. After its review and analysis of the

evidence, the Update Committee concluded that no revisions

to the existing ASCO recommendations were warranted.

Regular history, physical examination, and mammography are

recommended for breast cancer follow-up. Physical

examinations should be performed every 3 to 6 months for the

first 3 years, every 6 to 12 months for years 4 and 5, and

annually thereafter. For women who have undergone breast-

conserving surgery, a post-treatment mammogram should be

obtained 1 year after the initial mammogram and at least 6

months after completion of radiation therapy. Thereafter,

unless otherwise indicated, a yearly mammographic evaluation

should be performed. The use of complete blood counts,

chemistry panels, bone scans, chest radiographs, liver

ultrasounds, pelvic ultrasounds, computed tomography scans,

[(18)F]fluorodeoxyglucose-positron emission tomography

scans, MRI, and/or tumor markers (carcinoembryonic antigen,

CA 15-3, and CA 27.29) is not recommended for routine

follow-up in an otherwise asymptomatic patient with no specific

findings on clinical examination.

Korteweg et al (2011) evaluated the feasibility of 7-T breast

MRI by determining the intrinsic sensitivity gain compared with

3-T in healthy volunteers and explored clinical application of

7-T MRI in breast cancer patients receiving neoadjuvant

chemotherapy (NAC). In 5 volunteers, the signal-to-noise ratio

(SNR) was determined on proton density MRI at 3-T using a

conventional 4-channel bilateral breast coil and at 7-T using a

dedicated 2-channel unilateral breast coil, both obtained at

identical scan parameters. Subsequently, consecutive breast

cancer patients on NAC were included. The 7-T breast MRI

protocol consisted of diffusion-weighted imaging, 3-D high-

resolution (450 μm isotropic) T1-weighted fat-suppressed

gradient-echo sequences and quantified single voxel (1)

H-magnetic resonance spectroscopy. Morphology was scored

according to the MRI Breast Imaging-Reporting and Data

System (BI-RADS)-lexicon, and the images were compared

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with 3-T and histopathologic findings. Image quality was

evaluated using a 5-point scale. A 5.7-fold higher SNR was

measured at 7-T than at 3-T, which reflected the advantages

of a higher field strength and the use of optimized

radiofrequency coils. Three breast cancer patients were

included and received a total of 13 7-T MRI examinations.

The image quality of the high-resolution examinations was at

least satisfactory, and good to excellent in 9 of the 13

examinations performed. More anatomic detail was depicted

at 7-T than at 3-T. In 1 case, a fat plane between the muscle

and tumor was visible at 7-T, but not at the clinically performed

3-T examination, suggesting that there was no muscle

invasion, which was confirmed by pathology. Changes in

tumor apparent diffusion coefficient values could be monitored

in 2 patients and were found to increase during NAC,

consistent with published results from studies at lower field

strengths. Apparent diffusion coefficient values increased

respectively from 0.33 × 10(-3) mm(2)/s to 1.78 × 10(-3) mm

(2)/s after NAC and from 1.20 × 10(-3) mm(2)/s to 1.44 × 10

(-3) mm(2)/s during NAC. Choline concentrations as low as

0.77 mM/kg(water) could be detected. In 1 patient, choline

levels showed an overall decrease from 4.2 mM/kg(water) to

2.6 mM/kg(water) after NAC and the tumor size decreased

correspondingly from 3.9 × 4.1 × 5.6 cm(3) to 2.0 × 2.7 × 2.4

cm(3). All 7-T MRI findings were consistent with pathology

analysis. The authors concluded that dedicated 7-T breast

MRI is technically feasible, can provide more SNR than at 3-T,

and has diagnostic potential.

An UpToDate review on “MRI of the breast and emerging

technologies” (Slanetz, 2014) states that “High field strength

MRI -- High field strength magnets (3-Tesla and 7-Tesla)

provide higher signal to noise ratios than conventional breast

MRI, performed with 1.5-Tesla field strength magnets. The

high field strength magnets result in higher spatial resolution

and improved detection of breast cancers <5 mm in size than

conventional techniques. However, there are no large

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prospective trials that show clinical advantage for high field

strength MRI. In addition, the lack of widespread availability of

higher field magnets limits applicability to clinical practice”.

Diagnosis of Fat Necrosis Post-Breast Reduction Surgery

Tuncbilek et al (2011) stated that non-traumatic rapid growing

giant fat necrosis of the breast mimicking breast tumors is a

rare clinical manifestation. The imaging features of the fat

necrosis that range from benign to malign findings may be

better explained with associated etiology. These researchers

reported the case of a 54-year old woman with a rapid

growing, fibrous, and hard giant mass originating in the sub-

areolar region of the left breast. Mammography and MRI

demonstrated a heterogeneous, well circumscribed mass in 12

× 12 cm size in the left breast. The lesion was suspected as a

malignant tumor and underwent core biopsy. The

histopathology examination of the biopsy revealed

mononuclear cells, foamy, vacuolated, and bubbly cells

containing fat. Excision biopsy of the mass was performed

and the final pathological diagnosis was confirmed as fat

necrosis. The authors concluded that the wide clinical and

radiologic manifestations of fat necrosis are still difficult to

diagnose even with the new diagnostic modalities and a great

proportion of these lesions need a biopsy to diagnose.

The American College of Radiology (ACR)’s Appropriateness

Criteria on “Nonpalpable mammographic findings (excluding

calcifications)” (2012) suggested considering “Return to

screening mammography if the area can be confidently

determined to be related to prior surgery (i.e., by scar marker)

or the sequelae of trauma (e.g., presence of fat necrosis)”.

This was rendered a “4” rating (4, 5, 6 ratings denote “May be

appropriate”). The ACR’s Appropriateness Criteria on

“Nonpalpable mammographic findings (excluding

calcifications)” does not mention the use of MRI.

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Kerridge et al (2015) stated that “Fat necrosis of the breast is a

challenging diagnosis due to the various appearances on

mammography, ultrasound, CT, positron emission

tomography-computed tomography (PET-CT), and MRI.

Although mammography is more specific, ultrasound is a very

important tool in making the diagnosis of fat necrosis. MRI has

a wide spectrum of findings for fat necrosis and the

appearance is the result of the amount of the inflammatory

reaction, the amount of liquefied fat, and the degree of

fibrosis”. In fact, specificity of post-operative MRI may be

lowered by enhancing granulation tissue or fat necrosis at the

surgical site.

An eMedicine’s review on “Postsurgical Breast

Imaging” (Ackerman, 2015) did not mention breastMRI as a

diagnostic tool for fat necrosis of the breast.

Furthermore, Radiopaedia.org’s Information Sheet on “Fat

Necrosis of the Breast” (2015) stated that “Fat necrosis within

the breast is a pathological process that occurs when there is

saponification of local fat. It is a benign inflammatory process

and is becoming increasingly common with greater use of

breast conserving surgery and mammoplasty procedures”. It

mentions mammography and breast ultrasound for the

diagnosis of fat necrosis; but not breast MRI.

Routine Screening/Evaluation of Individuals with Nipple Discharge

The Institute for Clinical Systems Improvement’s clinical

guideline on “Diagnosis of breast disease” (ICSI, 2012)

provided the following information

▪ Patients with a bloody or clear discharge should be

referred to a radiologist and/or surgeon for further

evaluation

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▪ A mammogram and ultrasound should be obtained with

presence of bloody or clear discharge to rule out

malignancy

▪ Most pathologic nipple discharges should be treated

with duct excision. The use of ductography and/or MRI

ductography is dependent on the decision of the

surgeon and radiologist.

The Alberta Provincial Breast Tumor Team’s clinical guide l ine

on “Magnetic resonance imaging for breast cancer screening,

pre-operative assessment, and follow-up” (2012) stated that:

▪ MRI is not recommended for the routine screening of

patients with nipple discharge.

van Gelder et al (2015) noted that unilateral bloody nipple

discharge (UBND) is mostly caused by benign conditions such

as papilloma or ductal ectasia. However, in 7 to 33 % of all

nipple discharge, it is caused by breast cancer. Conventional

diagnostic imaging like mammography (MMG) and

ultrasonography (US) is performed to exclude malignancy.

Preliminary investigations of breast magnetic resonance

imaging (MRI) assume that it has additional value. With an

increasing availability of MRI, it is of clinical importance to

evaluate this. These investigators evaluated the additional

diagnostic value of MRI in patients with UBND in the absence

of a palpable mass, with normal conventional imaging. All

women with UBND in the period November 2007 to July 2012

were included. In addition to the standard work-up (patient's

history, physical examination, MMG, and US), MRI was

performed. Data from these examinations and treatment were

collected retrospectively. A total of 111 women (mean age 52

years; range of 23 to 80) were included. In 9 (8 %) patients,

malignancy was suspected on MRI while conventional imaging

was normal. In 8 (89 %) of these patients, histology was

obtained, 2 by core biopsy and 6 by terminal duct excision.

Benign conditions were found in 6 patients (86 %) and a (pre)

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malignant lesion in 2 patients. In both cases, it concerned a

ductal carcinoma in-situ, which was treated with breast-

conserving therapy. Moreover, in 2 cases of (pre)malignancy,

the MRI was interpreted as negative. The authors concluded

that in patients with UBND who showed no signs of a

malignancy on conventional diagnostic examinations, the

added value of a breast MRI is limited, since a malignancy can

be demonstrated in less than 2 %.

An UpToDate review on “Nipple discharge” (Golshan and

Iglehart, 2015) states that “Magnetic resonance imaging -- MRI

is a relatively sensitive imaging modality with low to moderate

specificity. The role of MRI in the evaluation of nipple

discharge is evolving. In 52 patients with suspicious nipple

discharge who were studied with a breast MRI; the sensitivity

and specificity for malignancy were 77 and 62 %, respectively,

with a median follow-up of 14 months. The positive predictive

value of MRI in this series was 56 %. The significant false

positive rate and somewhat limited availability of MR-guided

biopsy limits the utility of this modality. If MR is going to be

used in this setting, it should be done in a facility that has MR

biopsy capabilities. MR ductography -- MR ductography is a

different technique than standard breast MRI. It utilizes heavy

T2 weighting, which accentuates the visibility of fluid

containing structures. No directly instilled or intravenous

contrast material is necessary. MR ductography provides a 3D

image and can show the precise shape and location of the

abnormal duct and lesion in the breast. However, this

technique will not reveal ducts that are not dilated or those

with low signal intensity on heavily T2-weighted images, due to

hemorrhage or the presence of proteinaceous contents within

the duct …. The workup of suspicious nipple discharge should

include ultrasound and mammography. The role of imaging is

to determine whether there are any underlying lesions that

may account for the symptom of nipple discharge and to target

the area for surgical localization. However, imaging studies do

not reliably identify cancer or high-risk lesions in patients with

nipple discharge. Other diagnostic testing, including

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ductography, breast magnetic resonance imaging, magnetic

resonance ductography, and ductoscopy can be helpful in

selected women but are not routinely necessary for the work-

up of nipple discharge”.

Furthermore, an UpToDate review on “MRI of the breast and

emerging technologies” (Slanetz, 2015) states that “Although

some have proposed breast MRI imaging for the evaluation of

spontaneous nipple discharge when mammography and

ultrasound of the periareolar area fail to identify a focal finding,

we do not feel there is a role for MRI for this purpose. A

negative MRI does not preclude disease and pathologic nipple

discharge should be managed with a terminal duct excision”.

Post-Surgical Intra-Operative Breast MRI for Quantifying Tumor Deformation and Detecting Residual Breast Cancer

Gombos and associates (2016) employed intra-operative

supine MRI to quantify breast tumor deformation and

displacement secondary to the change in patient positioning

from imaging (prone) to surgery (supine) and evaluated

residual tumor immediately after breast-conserving surgery

(BCS). A total of 15 women gave informed written consent to

participate in this prospective HIPAA-compliant, institutional

review board-approved study between April 2012and

November 2014; 12 patients underwent lumpectomy and post-

surgical intra-operative supine MRI; 6 of 12 patients underwent

both pre- and post-surgical supine MRI. Geometric, structural,

and heterogeneity metrics of the cancer and distances of the

tumor from the nipple, chest wall, and skin were computed.

Mean and standard deviations (SDs) of the changes in

volume, surface area, compactness, spherical disproportion,

sphericity, and distances from key landmarks were computed

from tumor models. Imaging duration was recorded. The

mean differences in tumor deformation metrics between prone

and supine imaging were as follows: volume, 23.8 % (range of

-30 % to 103.95 %); surface area, 6.5 % (range of -13.24 % to

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63 %); compactness, 16.2 % (range of -23 % to 47.3 %);

sphericity, 6.8 % (range of -9.10 % to 20.78 %); and decrease

in spherical disproportion, -11.3 % (range of -60.81 % to 76.95

%). All tumors were closer to the chest wall on supine images

than on prone images. No evidence of residual tumor was

seen on MRI obtained after the procedures. Mean duration of

pre- and post-operative supine MRI was 25 minutes (range of

18.4 to 31.6 minutes) and 19 minutes (range of 15.1 to 22.9

minutes), respectively. The authors concluded t hat intra-

operative supine breast MRI, when performed in conjunction

with standard prone breast MI, enabled quantification of breast

tumor deformation and di splacement secondary to changes in

patient positioning from standard i maging (prone) to surgery

(supine) and may help clinicians evaluate for residual tumor

immediately after BCS. These preliminary findings need to be

validated by well-designed studies.

Quantitative Breast MRI Predicting the Risk of Breast Cancer Recurrence

Li and colleagues (2016) examined the relationships between

computer-extracted breast MRI phenotypes with multi-gene

assays of MammaPrint, Oncotype DX, and PAM50 to assess

the role of radiomics in evaluating the risk of breast cancer

recurrence. Analysis was conducted on an institutional review

board-approved retrospective data set of 84 de-identified, multi-

institutional breast MR examinations from the National Cancer

Institute Cancer Imaging Archive, along with clinical,

histopathological, and genomic data from the Cancer Genome

Atlas. The data set of biopsy-proven invasive breast cancers

included 74 (88 %) ductal, 8 (10 %) lobular, and 2 (2 %) mixed

cancers. Of these, 73 (87 %) were estrogen receptor (ER)

-positive, 67 (80 %) were progesterone receptor (PR)-positive,

and 19 (23 %) were human epidermal growth factor receptor

(EGFR)2-positive. For each case, computerized radiomics of

the MRI yielded computer-extracted tumor phenotypes of size,

shape, margin morphology, enhancement texture, and kinetic

assessment. Regression and receiver operating characteristic

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analysis were conducted to assess the predictive ability of the

MR radiomics features relative to the multigene assay

classifications. Results Multiple linear regression analyses

demonstrated significant associations (R2 = 0.25 to 0.32, r =

0.5 to 0.56, p < 0.0001) between radiomics signatures and

multi-gene assay recurrence scores. Important radiomics

features included t umor size and enhancement texture, which

indicated tumor heterogeneity. Use of radiomics in the task of

distinguishing between good and poor prognosis yielded area

under the receiver operating characteristic curve values of

0.88 (standard error [SE], 0.05), 0.76 (SE, 0.06), 0.68 (SE,

0.08), and 0.55 (SE, 0.09) for MammaPrint, Oncotype DX,

PAM50 risk of relapse based on subtype, and PAM50 risk of

relapse based on subtype and proliferation, respectively, with

all but the latter showing statistical difference from chance.

The authors concluded that quantitative breast MRI radiomics

showed promise f or image-based phenotyping in assessing

the risk of breast cancer recurrence.

Surveillance in Women after Breast Conservation Therapy

In a prospective study, Kim and colleagues (2017) examined

the diagnostic performance and tissue changes in early (1

year or less) breast MRI surveillance in women who underwent

BCS for breast cancer. Between April 2014 and June 2016, a

total of 414 women (mean age of 51.5 years; range of 21 to 81

years) who underwent 422 early surveillance breast MRI

examinations (median of 6.0 months; range of 2 to 12 months)

after BCS were studied. The cancer detection rate, PPV of

biopsy, sensitivity, specificity, accuracy, and area under the

curve (AUC) of surveillance MRI, mammography, and US were

assessed. Follow-up was also obtained in 95 women by using

PET/ CT. Background parenchymal enhancement (BPE)

changes in the contralateral breast were assessed according

to adjuvant therapy by using the McNemar test. Of 11

detected cancers, 6 were seen at MRI only, 1 was seen at MRI

and mammography, 2 were seen at MRI and US, 1 was seen

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at mammography only, and 1 was seen at PET/CT only; 3

MRI-depicted cancers were observed at the original tumor

bed, and 2 MRI-depicted cancers were observed adjacent to

the original tumor. Among 2 false-negative MRI diagnoses (2

cases of ductal carcinoma in-situ [DCIS]), 1 cancer had

manifested as calcifications at mammography without

differentiated enhancement at MRI, and the other cancer was

detected at PET/CT, but MRI results were negative because of

marked BPE, which resulted in focal lesion masking. The PPV

of biopsy and the sensitivity, specificity, accuracy,and AUC for

MR imaging were 32.1 % (9 of 28), 81.8 % (9 of 11), 95.1 %

(391 of 411), 94.7 % (400 of 422), and 0.88, respectively. The

sensitivity of surveillance MRI (81.8 %; 95 % CI: 48.2 % to

97.7 %) was higher than that of mammography (18.2 %; 95 %

CI: 2.3 % to 51.8 %) and US (18.2 %; 95 % CI: 2.3 % to 51.8

%), with an overlap in CIs. The BPE showed a significant

decrease in the group of patients who received adjuvant

chemotherapy (43 BPE decreases and 4 BPE increases) and

the group of patients who received hormone therapy (55 BPE

decreases and 2 BPE increases) (p < 0.0001 for both). The

authors concluded that early MRI surveillance af ter BCS can

be useful in patients who have breast cancer, with superior

sensitivity compared with that of mammography and US. The

BPE tends to be decreased at short-term follow-up MRI in

patients who receive adjuvant therapy.

Cho and co-workers (2017) noted that younger women (aged

less than or equal to 50 years) who underwent BCS may

benefit from breast MRI screening as an adjunct to

mammography. In a prospective, multi-center, non-

randomized study, these researchers ascertained the cancer

yield and tumor characteristics of combined mammography

with MRI or US screening in women who underwent BCS for

breast cancers and who were 50 years or younger at initial

diagnosis. This trial was conducted from December 1, 2010,

to January 31, 2016, at 6 academic institutions. A total of 754

women who were 50 years or younger at initial diagnosis and

who had undergone BCS for breast cancer were recruited to

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participate in the study. Reference standard was defined as a

combination of pathology and 12-month follow-up.

Participants underwent 3 annual MRI screenings of the

conserved and contralateral breasts in addition to

mammography and US, with independent readings. Main

outcomes measures were cancer detection rate (CDR),

sensitivity, specificity, interval cancer rate, and characteristics

of detected cancers. Subjects underwent a total of 2,065

mammograms, US, and MRI screenings; 17 cancers were

diagnosed, and most of the detected cancers (13 of 17 [76 %])

were stage 0 or stage 1. Overall cancer detection rate (8.2

versus 4.4 per 1,000; p = 0.003) or sensitivity (100 % versus

53 %; p = 0.01) of mammography with MRI was higher than

that of mammography alone. After the addition of US, the

cancer detection rate was higher than that by mammography

alone (6.8 versus 4.4 per 1,000; p =  0.03). The specificity of

mammography with MRI or US was lower than that by

mammography alone (87 % or 88 % versus 96 %; p <  0.001).

No interval cancer was found. The authors concluded that the

findings of this study suggested that the addition of MRI to

mammography screening improved the detection of early-

stage breast cancers at acceptable specificity in women who

had BCS at 50 years or younger. They stated that these

results can be used not only to inform patient and clinician

decision-making regarding the best methods of screening after

BCS but also to develop more personalized screening

guidelines and recommendations for women at increased risk

for breast cancer.

The National Cancer Institute’s Breast cancer screening (PDQ)

(2017) stated that breast MRI is used in women for diagnostic

evaluation, including evaluating the integrity of silicone breast

implants, assessing palpable masses after surgery or radiation

therapy, detecting mammographically and sonographically

occult breast cancer in patients with axillary nodal metastasis,

and pre-operative planning for some patients with known

breast cancer.|

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Furthermore, the American Society of Breast Surgeons’

“Consensus Guideline on Diagnostic and Screening Magnetic

Resonance Imaging of the Breast” (2017) support the use of

breast MRI for the further evaluation of suspicious clinical or

imaging findings that remain indeterminate after complete

mammographic and sonographic evaluations.

Screening MRI in Women with a Person History of Breast Cancer

Lehman et al (2016) noted that screening MRI is

recommended for individuals at high-risk for breast cancer,

based on genetic risk or family history (GFH); however, there

is insufficient evidence to support screening MRI for women

with a personal history (PH) of breast cancer. These

researchers compared screening MRI performance in women

with PH versus GFH of breast cancer. They analyzed case-

series registry data, collected at time of MRI and at 12-month

follow-up, from their regional Clinical Oncology Data

Integration project. MRI performance was compared in women

with PH with those with GFH. Chi-square testing was used to

identify associations between age, prior history of MRI, and

clinical indication with MRI performance; logistic regression

was used to determine the combined contribution of these

variables in predicting risk of a false-positive exam. All

statistical tests were 2-sided. Of 1,521 women who underwent

screening MRI from July 2004 to November 2011, 915 had PH

and 606 had GFH of breast cancer. Overall, MRI sensitivity

was 79.4 % for all cancers and 88.5 % for invasive cancers.

False-positive exams were lower in the PH versus GFH groups

(12.3 % versus 21.6 %, p < 0.001), specificity was higher (94.0

% versus 86.0 %, p < 0.001), and sensitivity and cancer

detection rate were not statistically different (p > 0.99). Age (p

< 0.001), prior MRI (p < 0.001), and clinical indication ( p <

0.001) were individually associated with initial false-positive

rate; age and prior MRI remained statistically significant in

multi-variable modeling (p = 0.001 and p < 0.001,

respectively). The authors concluded that MRI performance

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was superior in women with PH compared with women with

GFH. They stated that screening MRI warrants consideration

as an adjunct to mammography in women with a PH of breast

cancer. They stated that these findings suggested that MRI

can enhance surveillance in women with a personal history of

breast cancer by detecting mammographically occult invasive

breast cancers while they are small and node-negative.

The authors stated that this study had limitation.First, it did not

have detailed treatment history on all patients, nor sufficient

numbers to compare smaller subgroups within the personal

history cohort. These areas are important topics for further

study. Also, these findings were from a single center, where

breast MRI surveillance in women with a PH of breast cancer

was used based on individual discussions of patients with their

care providers. At the authors ’institution, decisions regarding

MR surveillance were made on a case-by-case basis and after

discussion of potential benefits and harms. In general, MRI

tends to be offered more to women with dense breast tissue

who are young and whose primary breast cancer was

mammographically occult, but the decisions vary based on

provider and patient-shared decision-making. Currently, given

the equivocal recommendations by organizations with

guidelines for surveillance of women following treatment, there

is likely variation in practice of surveillance MRI after

successful breast cancer treatment both within and outside of

the authors’ center. At their institution, surveillance MRI may

be more common, while at other institutions MRI may be

reserved for those considered at the very highest risk for

recurrence (i.e., patients with prior high-risk cancers or

patients who did not receive radiation after breast-conserving

surgery or who did not complete recommended hormonal

therapy).

Commenting on the afore-mentioned study, Evans and

Maxwell (2016) stated the following:

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The authors did admit some other drawbacks to the study,

including lack of treatment information and pathology of prior

cancers; 4 of the breast cancers did not have information on

whether they were ipsilateral or contralateral, and of the 16

with information half were ipsilateral, with most having the

same pathology, suggesting they were recurrences rather than

new primaries. Other drawbacks include the fact that the MRI

scans were not read independently of the mammography

findings and the diagnostic contribution of mammography was

not presented, and it was therefore impossible to ascertain

from these data the added effect of MRI on cancer detection

and false-positive rates.

The authors pointed out that there were currently no

recommendations in the United States for MRI surveillance of

PH women. MRI screening of GFH women at very high-risk

and who had a personal history of breast cancer is

recommended in guidelines outside the United States, but MRI

is not recommended for follow-up of PH women who are not

otherwise at increased risk. The authors should nonetheless

be congratulated for collating data that reflect current practice

of MRI screening of higher-risk women in the United States,

and the data did suggest that MRI may be a useful tool in early

detection in the PH group, with better overall performance than

in the predominantly moderate risk GFH group.

Although prevention of further primaries by risk-reducing

mastectomy improves survival in women with BRCA

mutations, there are still conflicting results regarding whether

MRI in BRCA1 GFH women improves survival, and it may be

more effective in BRCA2 and other women at very high-risk.

There is some evidence in PH women that early detection of

recurrences and new primaries with mammography improves

survival, and other studies have suggested an additional

diagnostic benefit of MRI over mammography although no

survival advantage has been established. Nonetheless,

selective use of MRI for post-treatment surveillance in those at

high-risk of recurrence or in whom further malignancy may be

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otherwise difficult to detect (young women, those with dense

breasts, and those with a mammographically occult first

cancer) may have a place. A prospective multi-center study

would help to answer these important questions.

Hedge et al (2017) stated that for women with a personal

history of breast cancer (PHBC), no validated mechanisms

exist to calculate future contralateral breast cancer (CBC) risk.

The Manchester risk stratification guidelines were developed

to evaluate CBC risk in women with a PHBC, primarily for

surgical decision-making. This tool may be informative for the

use of MRI screening, as CBC risk is an assumed

consideration for high-risk surveillance. A total of 322 women

with a PHBC were treated with unilateral surgery within the

authors’ multi-disciplinary breast clinic. These researchers

calculated lifetime CBC risk using the Manchester tool, which

incorporates age at diagnosis, family history, genetic mutation

status, estrogen receptor positivity, and endocrine therapy

use. Uni-variate and multi-variate logistic regression analyses

(UVA/MVA) were performed, evaluating whether CBC risk

predicted MRI surveillance. For women with invasive disease

undergoing MRI surveillance, 66 % had low, 23 % above-

average, and 11 % moderate/high risk for CBC. On MVA,

previous mammography-occult breast cancer [odds ratio (OR)

18.95,p < 0.0001], endocrine therapy use (OR 3.89,p =

0.009), dense breast tissue (OR 3.69, p = 0.0007),

mastectomy versus lumpectomy (OR 3.12, p = 0.0041), and

CBC risk (OR 3.17 for every 10 % increase, p = 0.0002) were

associated with MRI surveillance. No pathologic factors

increasing ipsilateral breast cancer recurrence were significant

on MVA. The authors concluded that although CBC risk

predicted MRI surveillance, 89 % with invasive disease

undergoing MRI had less than 20% calculated CBC risk.

Concerns related to future breast cancer detectability (dense

breasts and/or previous mammography-occult disease)

predominate decision-making. Pathologic factors important for

determining ipsilateral recurrence risk, aside from age, were

not associated with MRI surveillance.

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The authors stated that this study had several limitations.

Given the retrospective nature of this analysis, it was possible

that there was incomplete information about the actual clinical

decision making used for selecting MRI surveillance. Also,

given that study was limited to a single institution, there were

institutional and patient cohort qualities that may have

introduced selection bias. Patient preference was not a factor

noted in the medical records, although this may have been an

unrecorded aspect to decision-making for MRI surveillance

utilization. Furthermore, while the decision for MRI surveillance

was made as part of a multi-disciplinary discussion, formal

institutional standards were not in place for this decision-

making. In addition, some patients who were undergoing

mammography alone may be doing so based on health

insurance-based factors or an inability to pay out-of-pocket for

MRI surveillance, although this was a factor that was difficult to

discern from retrospective medical record review. With that

noted, few patients (4 %) met NCCN indications for MRI

surveillance based on CBC risk and did not receive it.

Moreover, to maximize statistical power for comparison,

categories like breast density had multiple stratifications

grouped together. Perhaps with a larger sample size and with

more categories delineated, different results may be found.

Lastly, this study examined predictors for MRI surveillance use

and evaluated the rationale recorded for recommending this

surveillance tool. However, it did not evaluate the actual

outcomes of MRI surveillance in this cohort, as the cohort

follow-up time was too short to do so (all patients were treated

within the past 5 years). This analysis also did not specifically

account for ipsilateral breast cancer recurrence risk, although

the pathologic factors associated with this risk were all

individually noted to be insignificant on MVA for the selection

of MRI surveillance. Moreover, the Manchester algorithm has

yet to undergo additional validation studies to ensure that it

reliably calculates CBC risk. Finally, additional factors

including breast tissue density may impact CBC risk and yet

are not formally included in the Manchester tool.

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Park and colleagues (2018) noted that women with a PH of

breast cancer are at increased risk of future breast cancer

events, and may benefit from supplemental screening

methods that could enhance early detection of subclinical

disease. However, current literature on breast MRI

surveillance is limited. These researchers examined outcomes

of surveillance breast MRI in women with a PH of breast

cancer. They reviewed 1,053 consecutive breast MR

examinations that were performed for surveillance in 1,044

women (median age of 53 years; range of 20 to 85 years)

previously treated for breast cancer between August 2014 and

February 2016. All patients had previously received

supplemental surveillance with ultrasound. Cancer detection

rate (CDR), abnormal interpretation rate and characteristics of

MR-detected cancers were assessed, including extra-

mammary cancers. These investigators also calculated the

PPV1 , PPV3 , sensitivity and specificity for MR-detected intra-

mammary lesions. Performance statistics were stratified by

interval following initial surgery. The CDR for MR-detected

cancers was 6.7 per 1,000 examinations (7 of ,1053) and was

3.8 per 1,000 examinations (4 of 1,053) for intra-mammary

cancers. The overall abnormal interpretation r ate was 8.0 %,

and the abnormal interpretation rate for intra-mammary lesions

was 7.2 %. The PPV1, PPV3, sensitivity and specificity for intra-

mammary lesions was 5.3 % (4 of 76), 15.8 % (3 of 19),

75.0 % (3 of 4) and 98.3 % (1,031 of 1,049), respectively. For

MR examinations performed less than or equal to 36 months

after surgery, the overall CDR was 1.4 per 1,000

examinations. For MR examinations performed greater than 36

months after surgery, the overall CDR was 17.4 per 1,000

examinations. The authors concluded t hat these findings

suggested that surveillance breast MR imaging may be

considered in women with a history of breast cancer,

considering the low abnormal interpretation rate and its high

specificity. However, the cancer detection rate was low and

implementation may be more effective after more than 3 years

after surgery. Moreover, these researchers stated that further

research on the appropriate timing for surveillance breast MR

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imaging initiation is needed, especially in patients who have

undergone pre-operative breast MR imaging and supplemental

surveillance US.

The authors noted that this study had several drawbacks. First,

this was a retrospective study from a single institution.

Although their institution recently implemented breast MRI into

their post-treatment surveillance protocol to be performed 2

and 5 years after surgery, MRI was also performed at the

request of clinicians or patients and therefore, the intervals

between surgery and MRI were variable. Second, patients

underwent surveillance with mammography and US prior to

MRI, which could have affected the true cancer yield of MRI.

Third, the median interval between initial breast cancer

surgery and 1st-time surveillance MR examination (30.1

months, range of 12.1 to 240.2 months) was relatively short.

Breast MRI for Further Evaluation of Equivocal Findings on Digital Breast Tomosynthesis

Niell and colleagues (2018) evaluated the utility of MRI as a

problem-solving tool for equivocal findings on diagnostic DM)

and DBT. Breast MRI examinations performed from March

2011 to November 2014 were retrospectively reviewed to

identify those examinations that were performed to further

assess equivocal findings on combined DM and DBT

(DM/DBT) examinations. All patients underwent diagnostic

ultrasound (US) in conjunction with their DM/DBT

examination. Imaging reports were retrospectively reviewed

for BI-RADS findings and assessments of diagnostic DM/DBT

and diagnostic MRI examinations. A review of the electronic

medical records provided information on demographic data,

cancer diagnoses, and pathologic findings. Differences in the

PPV and negative predictive values (NPVs) of DM/DBT and

MRI were compared using a generalized estimating equation

for correlated binary data. Of 5,330 MRI examinations

performed during the study, 67 (1 %) were performed for

evaluation of an equivocal finding, including 27 asymmetries

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(40 %), 16 focal asymmetries (24 %), 5 masses (7 %), and 19

architectural distortion (28 %); MRI correlates were identified in

22 of 67 examinations (33 %). Biopsies yielded a cancer

diagnosis for 5 of 67 patients (7 %). For MRI, the PPV and

NPV were 19 % and 98 %, respectively, whereas for DM/DBT

they were 6 % and 90 %, respectively (p = 0.009 and p =

0.059, respectively). The frequency of recommendations for

breast MRI to evaluate equivocal findings decreased

exponentially in the 3 years after DBT implementation. The

authors concluded that as clinical implementation of DBT

becomes increasingly widespread, breast radiologists need an

algorithm for addressing the small number of inconclusive

findings that remain equivocal despite thorough DM/DBT and

US examinations. They stated that breast MRI is a useful

adjunctive tool for these selected cases.

Evaluation of Retro-Pectoral Fat Grafting in Breast Reduction

Guimaraes and colleagues (2019) noted that one of the

challenges in breast reduction is to maintain breast projection

with 45 % of its volume in the upper pole and 55 % in the

lower pole. Although widely used in breast surgeries, the

behavior of fat grafts is still not completely understood. In a

pilot study, these researchers evaluated by MRI the survival of

fat transferred to the retro-pectoral plane in patients

undergoing breast reduction, in the search for an oncologically

safe procedure with high predictability and reproducibility.

This trial was carried out with 7 patients who underwent breast

reduction combined with fat grafting in the sub-muscular plane;

aspirated fat was processed by sedimentation; MRI of the

breasts was performed pre-operatively and at 1 and 6 months

post-operatively. Fat survival was calculated as the difference

between the volumes of fat measured pre-operatively and

post-operatively by MRI divided by the volume of grafted fat. A

total of 14 breasts were operated on and received on average

119.6 ml of autologous fat in the sub-muscular plane. Fat

survival rate was 43.9 % at 1 month after surgery, decreasing

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to 23.4 % in the late post-operative period. The mean antero-

posterior projection of the grafted tissue was 1.51 cm at 1

month post-operatively, decreasing to 1.07 cm in the late post-

operative period. The authors concluded that retro-pectoral fat

grafting may contribute to maintaining the fullness of the upper

pole of the breasts. These investigators stated that this is an

innovative experimental model for future studies on fat

harvesting, preparation and grafting techniques, allowing the

evaluation of fat graft survival.

Breast MRI with Contrast for Follow-Up/Surveillance in Invasive Breast Cancer, or Ductal Carcinoma In Situ

According to NCCN’s Imaging Appropriate Use Criteria for

“Breast Cancer” (Version.2.2018), breast MRI with contrast is

not indicated for follow-up/surveillance in invasive breast

cancer, or DCIS.

Evaluation of Atypical Ductal Hyperplasia

An UpToDate review on “Atypia and lobular carcinoma in situ:

High-risk lesions of the breast” (Sabel and Collins, 2019)

states that “Magnetic resonance imaging (MRI) of the breast is

more sensitive than mammography in detecting invasive

breast cancers in high-risk women, but it is less specific,

especially for younger women. A large number of

unnecessary biopsies will be generated while finding cancer in

only a small group of patients. Despite that, MRI can detect

smaller cancers and more node-negative malignancies in high-

risk women than other imaging modalities; however, there is

no evidence for a reduction in mortality or improved disease-

free survival from screening with MRI. There are insufficient

data to support annual screening with MRI for women who are

of an average risk, or an intermediate risk, such as those with

a biopsy revealing AH or LCIS. A prospective database that

included 776 women with LCIS found that women screened

with MRI in addition to mammography and clinical breast

examinations (n = 455) had the same crude breast cancer

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detection rate of 13 % at a median of 58 months of follow-up.

MRI was not associated with earlier stage of detection, smaller

tumor size, or node negativity. Consequently, guidelines from

major groups, including the American Cancer Society (ACS)

and the NCCN, only integrate breast MRI into their

recommendations for breast cancer surveillance in high-risk

women (i.e., an estimated lifetime risk of breast cancer greater

than 20 to 25 %, calculated using BRCAPROor a similar

model based on family history, rather than the Gail model)”.

Quantitative Measurements of Breast Density

Sindi and colleagues (2019) noted that breast density, a

measure of dense fibro-glandular tissue relative to non-dense

fatty tissue, is confirmed as an independent risk factor of

breast cancer. Although there has been an increasing interest

in the quantitative assessment of breast density, no research

has examined the optimal technical approach of breast MRI in

this aspect.These researchers carried out a systematic

review and meta-analysis to analyze the current studies on

quantitative assessment of breast density using MRI and to

determine the most appropriate technical/operational protocol.

Databases (PubMed, Embase, ScienceDirect, and Web of

Science) were searched systematically for eligible studies.

Single-arm meta-analysis was conducted to determine

quantitative values of MRI in breast density assessments.

Combined means with their 95 % CI were calculated using a

fixed-effect model. Furthermore, subgroup meta-analyses

were performed with stratification by breast density

segmentation/measurement method. In addition, alternative

groupings based on statistical similarities were identified via a

cluster analysis employing study means and standard

deviations in a Nearest Neighbor/Single Linkage. A total of 38

studies matched the inclusion criteria for this systematic

review; 21 of these studies were judged to be eligible for meta-

analysis. The results indicated, generally, high levels of

heterogeneity between study means within groups and high

levels of heterogeneity between study variances within

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groups. The studies in 2 main clusters identified by the cluster

analysis were also subjected to meta-analyses. The review

confirmed high levels of heterogeneity within the breast

density studies, considered to be due mainly to the

applications of MR breast-imaging protocols and the use of

breast density segmentation/measurement methods. The

authors concluded that further research should be performed

to determine the most appropriate protocol and method for

quantifying breast density using MRI.

The authors stated that this meta-analysis had several

drawbacks. First, the heterogeneity of study aims, the study

design utilized, and the technical/operational methods applied,

for instance, the MR breast-imaging protocol, MR scanner

manufacturer, and the static magnetic field strength presented

challenges for performing the meta-analysis. Second, the

breast density segmentation/measurement algorithm used was

another drawback. Although these researchers classified the

included studies into discrete subgroups (i.e., FCM, FCM and

N3, and interactive semi-automated threshold), and applied

stratified analyses, the heterogeneity remained. Third, the

definition of the breast density was inconsistent because some

studies reported it as a percentage of dense breast volume,

while the others as a percentage of breast density. Fourth,

among the 38 studies included in this analysis, only 21 studies

were eligible for meta-analysis due to the statistical

requirements for the input values that should be in identical

expression of measurement and dispersion. Furthermore,

some of the included studies used the same set of the subject

multiple times for different purpose and feature. Although

these investigators decided to rectify the issue by selecting

one of the results of data at random, or by any meaningful

clinical criterion, the heterogeneity continued to exist.

Notwithstanding these drawbacks, the study further supported

the idea of developing a standard MRI protocol for the

quantitative assessment of breast density.

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Appendix

Breast Cancer Staging

Information about breast cancer staging is available from the

National Cancer Institute at the following website: Breast

Cancer Treatment

(http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3).

Breast Cancer Risk Assessment Models

Software for each of the breast cancer models referenced the

American Cancer Society guidelines (Saslow et al, 2007) is

available via the internet:

▪ BRCAPRO Version 4.3. Available at: U.T. Southwestern

CancerGene Software

(http://www4.utsouthwestern.edu/breasthealth/cagene/default.asp).

▪ Claus model (http://www.palmgear.com/index.cfm?

fuseaction=software.showsoftware&prodID=29820)

(BreastCa for Palm, version 1.0, copyright. 2001)

▪ Tyrer-Cuzick (IBIS Breast Cancer Risk Evaluation Tool,

RiskFileCalc version 1.0, copyright 2004). Available by

contacting IBIS:

[email protected] (mailto:[email protected]).

Breast cancer risk can also be estimated online using the Gail

Model Breast Cancer Risk Assessment Tool available from the

National Cancer Institute's website: Breast Cancer Risk

Assessment Tool (http://www.cancer.gov/bcrisktool/).

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

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Code Code Description

CPT codes covered if selection criteria are met:

19085 Biopsy, breast, with placement of breast

localization device(s) (eg, clip, metallic pellet),

when performed, and imaging of the biopsy

specimen, when performed, percutaneous; first

lesion, including m agnetic resonance guidance

19086 each additional lesion, including magnetic

resonance guidance (List separately in addition

to code for primary procedure)

19287 Placement of breast localization device(s) (eg

clip, metallic pellet, wire/needle, radioactive

seeds), percutaneous; first lesion, including

magnetic resonance guidance

19288 each additional lesion, including magnetic

resonance guidance (List separately in addition

to code for primary procedure)

77046 -

77047

Magnetic resonance imaging, breast, without

contrast material

77048 -

77049

Magnetic resonance imaging, breast, without

and with contrast material(s), including

computer-aided detection (CAD real-time lesion

detection, characterization and pharmacokinetic

analysis), when performed

Other CPT codes related to the CPB:

15769 Grafting of autologous soft tissue, other,

harvested by direct excision (eg, fat, dermis,

fascia)

15771 Grafting of autologous fat harvested by

liposuction technique to trunk, breasts, scalp,

arms, and/or legs; 50 cc or less injectate

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Code Code Description

+15772 each additional 50 cc injectate, or part

thereof (List separately in addition to code for

primary procedure)

19100 -

19103

Breast biopsy

19120 -

19126

Excision breast lesion

19300 -

19307

Mastectomy procedures

19357 -

19369

Breast reconstruction

20926 Tissue grafts, other (eg, paratenon, fat, dermis)

76641 Ultrasound, breast, unilateral, real time with

image documentation, including axilla when

performed; complete

76642 limited

77065 -

77067

Diagnostic mammography, including computer-

aided detection (CAD) when performed

88245 -

88269

Chromosome analysis

88271 -

88275

Molecular cytogenetics

HCP CS codes covered if selection criteria are met:

C 8903 Magnetic resonance imaging with contrast,

breast; unilateral

C 8904 Magnetic resonance imaging without contrast,

breast; unilateral

C 8905 Magnetic resonance imaging without contrast

followed by with contrast, breast; unilateral

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Code Code Description

C 8906 Magnetic resonance imaging with contrast,

breast; bilateral

C 8907 Magnetic resonance imaging without contrast,

breast; bilateral

C 8908 Magnetic resonance imaging without contrast

followed by with contrast, breast; bilateral

C 8937 Computer-aided detection, including computer

algorithm analysis of breast mri image data for

lesion detection/characterization,

pharmacokinetic analysis, with further physician

review for interpretation (list separately in

addition to code for primary procedure)

O ther HCPCS codes related to the CPB:

G0202 -

G0206

Mammography

L 8600 Implantable breast prosthesis, silicone or equal

ICD-10 codes covered if selection criteria are met:

C50.011 -

C 50.929

Malignantneoplasm of breast

C 77.3 Secondary and unspecified malignant

neoplasm of axilla and upper limb lymph nodes

C 79.81 Secondary malignant neoplasm of breast

D05.00 -

D05.92

Carcinoma in situ of breast

N60.81 -

N60.89

Other benign mammary dysplasias

N64.52 Nipple Discharge

N64.53 Retraction of nipple

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Code Code Description

Q85.8 Other phakomatoses, not elsewhere classified

[Cowden syndrome]

R 92.8 Other abnormal and inconclusive findings on

diagnostic imaging of breast

T85.41+ -

T85.49+

Mechanical complications of breast prosthesis

and implant

T85.690+

-

T85.698+

Other mechanical complications of other

specified internal prosthetic devices, implants

and grafts

Z12.31 -

Z12.39

Encounter for screening for malignant

neoplasm breast

Z15.01 Genetic susceptibility to malignant neoplasm of

breast [not covered for BRCA-positive men]

Z15.02 Genetic susceptibility to malignant neoplasm of

ovary

Z40.01 Prophylactic breast removal

Z40.02 Encounter for prophylactic removal of ovary(s)

Z80.3 Family history of malignant neoplasm of breast

Z80.41 Family history of malignant neoplasm of ovary

Z85.3 Personal history of malignant neoplasm of

breast

Z85.43 Personal history of malignant neoplasm of

ovary

Z90.10 -

Z90.13

Acquired absence of breast and nipple

Z92.3 Personal history of irradiation [to chest]

Z98.82 Breast implant status

ICD-10 codes not covered for indications listed in the CPB:

Proprietary

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Code Code Description

D24.1 -

D24.9

Benign neoplasm of breast

D48.60 -

D48.69

Neoplasm of uncertain behavior of breast

M33.00 -

M33.99

Dermatopolymyositis

N60.01 -

N60.09

Solitary cyst of breast

N60.11 -

N60.19

Diffuse cystic mastopathy

N60.21 -

N60.29

Fibroadenosis of breast

N64.1 Fat necrosis of breast

N64.9 Disorder of breast, unspecified

R92.0 Mammographic microcalcification found on

diagnostic imaging of breast

R99 Ill-defined and unknown cause of mortality

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors

in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely

responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is

subject to change.

Copyright © 2001-2020 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0105 Magnetic

Resonance Imaging (MRI) of the Breast

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania new 06/01/2020

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