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

2 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:

3 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

4 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)

5 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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7 TIMC Imaging Network GE CentricityAGFA ImpaxGE Centricity Fuji Synapse Tumor measurements workstation Image Archive & Webserver Database Images Data Results DICOM Gateways or LAN 2 LAN

8 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

99 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

10 TIMC Growth Scans analyzed

11 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

12 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)

13 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 SUV max TIMC Future

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15 Patient List

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