Transcript Presentation Title

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
•
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
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TIMC Mission: To support imaging
in oncology-based clinical trials
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Standardized measurements according to protocol
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Centralized image analysis to increase reliability
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Single Image Analyst per trial to decrease variability and
increase consistency
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Longitudinal tracking of treatment response
•
Web-based Computer Provider Order Entry (CPOE)
•
Web-based secure results reporting (tables, graphs &
images)
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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
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TIMC Services
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TIMC Imaging Network
GE Centricity
AGFA Impax
GE Centricity
GE Centricity
Fuji Synapse
DICOM Gateways
or LAN 2 LAN
Images
Images
Data Results
Tumor measurements
workstation
Image Archive &
Webserver Database
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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
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)
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TIMC Growth
TIMC Usage by Institution
800
CHMC
BIDM
Faulkner
MGH
BWH/DFCI
600
400
200
FY
08
Q4
FY
08
Q3
FY
08
Q2
20
08
Q1
20
07
Q3
20
07
Q4
20
07
Q2
0
20
07
Q1
Scans analyzed
1000
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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
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TIMC Service Fees (per scan)
Assessment Criteria
DF/HCC
Member
RECIST ch/ab/pel (CT/MR)
WHO neuro, ch/ab/pel (CT/MR)
Cheson (NHL) neck/ch/ab/pel (CT/MR)
SUV (PET)
Choi (CT w/contrast)
3D Volume – neuro (MR)
$100
$100
$125
$125
$150
$150
NonDF/HCC
Member
Industry
Sponsored
$200
$200
$250
$250
$300
$300
$300
$300
$375
$375
$450
$450
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TIMC Operating Budget
Funding source
FY05
FY06
FY07
FY08
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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
$112,600
$207,170
Total
$494,685 $793,900
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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
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TIMC Staff
Core Co-Directors:
MGH
Gordon J. Harris, Ph.D.
DFCI
Annick D. Van den Abbeele, M.D.
BWH
Matthew A. Barish, M.D.
MGH
Core Manager:
William B. Hanlon
MGH
Lead Analyst:
Trinity A. Urban
MGH
Research Fellow:
Marta Braschi, M.D.
BWH
Research Fellow:
Gisele P. Cruz, M.D.
Imaging Analyst:
Rob Zondervan BWH
MGH
DBA / Web Developer: Vadim Frenkel
For additional information, please visit our website:
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
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TIMC Results Report
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TIMC Results Report
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