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Problems with oncology-based clinical trials

Tumor Imaging Metrics Core A Centralized Service to Provide Standardized Tumor Measurements for Oncology Clinical Trials www.tumormetrics.org. Problems with oncology-based clinical trials. Need for standardized imaging measures for clinical trials Clinical read ≠ standardized assessment

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Problems with oncology-based clinical trials

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  1. Tumor Imaging Metrics CoreA Centralized Service to Provide Standardized Tumor Measurements for Oncology Clinical Trialswww.tumormetrics.org

  2. Problems with oncology-based clinical trials • 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

  3. 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)

  4. TIMC Services • 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

  5. TIMC Services

  6. TIMC Imaging Network GE Centricity AGFA Impax GE Centricity GE Centricity Fuji Synapse DICOM Gateways or LAN 2 LAN Images Images Data Results Image Archive & Webserver Database Tumor measurements workstation

  7. 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

  8. TIMC Experience 183 Active Trials • RECIST Criteria (139) (76%) • PET SUV Criteria (12) • Cheson Criteria for Lymphoma (9) • IWRC (9) • Brain Volumetrics (6) • WHO (5) • CHOI Criteria (3) 8

  9. TIMC Growth Scans analyzed

  10. TIMC History • 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

  11. TIMC Service Fees (per scan) 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

  12. TIMC Operating Budget • CCSG Grant $100,000 $100,000 $120,000 $120,000 • Chargebacks $12,600 $41,470 $233,935 $591,150 • Pharma Contracts $0 $65,700 $94,700 $35,250 • CCPO Agreement $0 $0 $35,000 $47,500 • Other Contracts $0 $0 $11,050 $0 Total $112,600 $207,170 $494,685 $793,900 Funding source FY05 FY06 FY07 FY08

  13. TIMC Future • 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 www.tumormetrics.org

  14. 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: 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

  15. John Doe *********

  16. Patient List

  17. TIMC Results Report

  18. TIMC Results Report

  19. TIMC Results Report

  20. TIMC Results Report

  21. TIMC Results Report

  22. TIMC Results Report

  23. TIMC Results Report

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