Tumor Imaging Metrics Core A Centralized Service to Provide Standardized Tumor Measurements for Oncology Clinical Trials .

Tumor Imaging Metrics Core

A Centralized Service to Provide Standardized Tumor Measurements for Oncology Clinical Trials

www.tumormetrics.org

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TIMC Staff

Core Co-Directors: Gordon J. Harris, Ph.D.MGH

Annick D. Van den Abbeele, M.D.DFCI

Matthew A. Barish, M.D. BWH

Core Manager: William B. Hanlon MGH

Lead Analyst: Trinity A. Urban MGH

Research Fellow: Marta Braschi, M.D. MGH

Research Fellow: Joe Ma, M.D. MGH

Research Fellow: Gisele P. Cruz, M.D. BWH

Imaging Analyst: Rob Zondervan BWH

DBA / Web Developer: Vadim Frenkel MGH

For additional information, please visit our website: www.tumormetrics.org

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• Need for standardized imaging measures for clinical trials

• Clinical read ≠ standardized assessment

• Inconsistent measurements

• Different raters across subjects and time points

• No image-based longitudinal record for reference

• Image data not available for audit

• Time-consuming for trials staff to get measurements

Problems with oncology-based clinical trials

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TIMC Mission: To support imaging in oncology-based clinical trials

• Standardized measurements according to protocol

• Centralized image analysis to increase reliability

• Single Image Analyst per trial to decrease variability and increase consistency

• Longitudinal tracking of treatment response

• Web-based Computer Provider Order Entry (CPOE)

• Web-based secure results reporting (tables, graphs & images)

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• Protocol Consultation• Consultative services for imaging components in trials

• Image Capture & Analysis• DICOM transfer from DF/HCC institutions’ PACS• Import of outside scans via secure internet or CD• MRI, CT, PET & multi-modality scans• Standardized linear, volumetric, SUV and Choi criteria

• Web-based Services• Login using PHS or BIDMC (CareWeb) username and password• Online Order-Entry for authorized users• Results viewable by study staff on a secure website• Centralized database for internal/external auditing

TIMC Services

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TIMC Services

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TIMC Imaging Network

GE Centricity AGFA Impax GE Centricity GE Centricity Fuji Synapse

Tumor measurements workstation

Image Archive & Webserver Database

Images Images

Data Results

DICOM Gateways or LAN 2 LAN

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TIMC Experience

• 230 trials (183 active, 47 completed and closed)

• 4,000 scans analyzed to date (Q4FY08)

• Five DF/HCC hospitals

• Twelve disease programs

• Most new trials now budget for TIMC services

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TIMC Experience

• RECIST Criteria (139) (76%)

• PET SUV Criteria (12)

• Cheson Criteria for Lymphoma (9)

• IWRC (9)

• Brain Volumetrics (6)

• WHO (5)

• CHOI Criteria (3)

183 Active Trials

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TIMC GrowthS

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TIMC Usage by Institution

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TIMC History• 2003 – Awarded 2004 Partners Radiology Research Award

• 2003 – PIs submit New Core proposal to DF/HCC

• 2004 – TIMC created as Core-in-Development, and

submitted as such for DF/HCC Competing Renewal

• 2005 – TIMC renewed as Core-in-Development as part of

DF/HCC competing renewal

• 2006 – TIMC began DF/HCC trials enrollment

• 2007 – TIMC is elevated to full core status by the EC

• 2008 – TIMC joins NCI IRAT network as a Corresponding

Member

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Non-

DF/HCC DF/HCC Industry

Assessment Criteria Member Member Sponsored

RECIST ch/ab/pel (CT/MR) $100 $200 $300

WHO neuro, ch/ab/pel (CT/MR) $100  $200 $300

Cheson (NHL) neck/ch/ab/pel (CT/MR) $125  $250 $375

SUV (PET) $125  $250 $375

Choi (CT w/contrast) $150  $300 $450

3D Volume – neuro (MR) $150  $300 $450

TIMC Service Fees (per scan)

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• Electronic signature in compliance with 21 CFR Part 11 Regulations

• Interfaces to Electronic Data Capture (EDC) systems

• Improved access to PACS

• Routine volumetrics to replace RECIST

• Advanced PET metrics to supplement SUVmax

TIMC Future

www.tumormetrics.org

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Patient List

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TIMC Results Report

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TIMC Results Report

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TIMC Results Report

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TIMC Results Report

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TIMC Results Report