ACRIN Breast Committee ACRIN Breast Committee Fall Meeting 2010 6657 Extension-CONTRAST-ENHANCED BREAST MRI and MRS FOR EVALUATION OF PATIENTS UNDERGOING NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED BREAST CANCER Nola Hylton ,PhD Constantine Gatsonis, PhD Pat Bolan, PhD 6657 Trial Team ACRIN Breast Committee
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ACRIN Breast Committee Fall Meeting 2010 6657 Extension-CONTRAST-ENHANCED BREAST MRI and MRS FOR EVALUATION OF PATIENTS UNDERGOING NEOADJUVANT TREATMENT.
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ACRIN Breast Committee
ACRIN Breast CommitteeFall Meeting 2010
6657 Extension-CONTRAST-ENHANCED BREAST MRI and MRS FOR EVALUATION OF PATIENTS UNDERGOING NEOADJUVANT TREATMENT FOR
LOCALLY ADVANCED BREAST CANCER
Nola Hylton ,PhDConstantine Gatsonis, PhD
Pat Bolan, PhD6657 Trial Team
ACRIN Breast Committee
ACRIN Breast Committee
ACRIN 6657 Trial Extension
Surgery
Anthracycline TaxaneClinicalStudy
MRI/MRS MRI/MRS MRI/MRS
Core biopsy
• Both CALGB 150007 and ACRIN 6657 were amended and re-opened in
September 2007; additional target accrual of 140 patients
• Same treatment paradigm as in original trials
• ACRIN 6657 amended to add single voxel 1H MR spectroscopy to the imaging
protocol; testing MRS [choline] as a marker of early response
• Short term endpoint used (pCR)
ACRIN Breast Committee
6657 Extension Aims
• New aims are testing total choline concentration [tCho]
measured by single voxel 1H MR spectroscopy following
1 cycle of chemotherapy for distinguishing responsive
and non-responsive tumors. Includes:
Reproducibility testing
1.5 T versus 3.0 T comparison
Acute (20-28 hour) versus persistent (48-96 hours) post treatment time
point comparison
ACRIN Breast Committee
6657 Extension Aims
• Accrual to-date:
114 patients accrued
96 enrolled at 1.5 T
16 enrolled at 3.0 T
44 enrolled at 20-28 hr
26 enrolled at 48-96 hr
28 enrolled outside of protocol time points
14 – time point data missing
• Analysis to-date
ACRIN Breast Committee
Design (ISMRM 2008 poster)
• Standard phantoms
• Entry and Weekly scanning
Motivation• Set entry threshold
• Monitor site consistency
• Acquire data for retrospective analysis- measurement precision (SE)
- compare fitting methods
- detection thresholds
- identify technical problems
Quality Control Phantom Scans
ACRIN Breast Committee
Vegetable oil
40 mm ø sphere w/ 1 mM PCho
20 mm voxel
2 liter bottle
ACRIN Breast Committee
Subject MRS Data Status
• 112 subjects as of 9/15
• Status is per-subject • both MR1 and MR2 must
be good
• No cho: • low snr (1.5T), difficult
voxel placements, too fatty
• No data• Some lost• Some not acq’d: why?
Good (32)
Pending Analysis
(9)
Pending Data (13)
withdrew / ineligible (9)
acquisition error (7)
no cho (20)
no data acquired /
submitted (22)
ACRIN Breast Committee
Example: Good quality
ACRIN Breast Committee
Example: No choline
ACRIN Breast Committee
Example: Acquisition error
ACRIN Breast Committee
Example: Analysis Pending
Choline peak is over-fit
ACRIN Breast Committee
MRS Data Quality, per-subject by Quartile
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q1 Q2 Q3 Q4
no choline
acq. error
Good
ACRIN Breast Committee
MRS Data by Field Strength
1.5T 3T
# subjects 96 (86%) 16 (14%)
Good data rate 48% 89%
Acq. error rate 14% 0%
No choline rate 38% 11%
ACRIN Breast Committee
Accrual ongoing
Early termination?• Competing with ISPY2
• Stopping pt analysis: • need 43 subjects with a drop in [tCho] and final path
• have 14 responders, 9 non-responders by [tCho] with path