tumor imaging metrics core a centralized service to provide standardized tumor measurements for...
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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
can
s a
nal
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TIMC Usage by Institution
0
200
400
600
800
1000
CHMCBIDMFaulknerMGHBWH/DFCI
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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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John Doe
*********
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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