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DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Development of a Centralized Service for Standardized Tumor
Measurements at a Multi-Institutional Collaborative
Cancer Center
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Core Co-leaders: Gordon J. Harris, Ph.D.1,4
Matthew A. Barish, M.D.2,4
Annick D. Van den Abbeele, M.D.3,4
Core Manager: William B. Hanlon1,4
Research Fellow: Vaibhav Sahai, M.D. 2, 4
Imaging Analyst: Trinity A. Urban1
DBA/Web Developer: Vadim Frenkel3
Administrator: Deirdre Pierce3
For additional information, please visit our website: www.tumormetrics.org
Tumor Imaging Metrics Core
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Tumor MetricsCurrent Shortcomings
*CRCs - Clinical Research Coordinators
Tumor Metrics for trials are not standard clinical care
• CT/MR-RECIST & PET-SUVmax not reported clinically
• No standardized system for RECIST requests
• CRCs* must ask individual radiologists
• No consistency of measurements
• No longitudinal records
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Mission
• Centralized image analysis to increase reliability
• Single image analyst and radiologist per trial to decrease variability and increase consistency
• Track longitudinal treatment response
• Web-based Computer Provider Order Entry (CPOE)
• Web-based secure results reporting (tables, graphs & images)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Core History• TIMC was established as a DF/HCC core in August ‘05• Enrollment in TIMC began in January ‘06
Usage Information• Currently 29 clinical trials
• Phase I, II, III• Lymphoma, Melanoma, Sarcoma, GIST• Colon, Lung, Pancreatic, Brain, Ovarian
and Breast Cancer
TIMC Clinical Trial Enrollment
02468
10
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06 Aug-06
Sep-06
Oct-06
# o
f Tri
als
TIMC Background
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Protocol Consultation• Consultative services for imaging components in trials
Image Capture & Analysis• DICOM transfer from DF/HCC institutions’ PACS• MRI, CT, PET & multi-modality scans• Standardized linear, volumetric & SUV criteria
Results Reporting• Results on a secure website• Centralized database for
internal/external auditing
TIMC Services
Individual Patient Response
Patient ID
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
Standard Operating Procedures• Image study management (image transfer and storage)• Tumor measurement guidelines and procedures• Database and reporting systems
Staff Training• Mandatory training for imaging analysts and radiologists• Inter-rater and intra-rater reliability tests• Reviewer manual (journal articles, teaching atlas,
practice scans)
TIMC Guidelines
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Services• Consultation
• Image Analysis• Image Archival
• Web-based Reporting
Clinical Research Coordinator
Imaging Department
Investigator
Image AnalystRadiologist
TIMC WorkflowClinical researcher
registers trialand
inputs request on TIMC web-based
Order Entry System
Website & Database
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Workflow
TIMC Services• Consultation
• Image Analysis• Image Archival
• Web-based Reporting
Clinical Research Coordinator
Investigator
Radiologist
Website & Database
Image Analyst
Image Analyst pulls scans from
DF/HCC institutions’ PACS
through the Imaging Network
Imaging Department
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Imaging Network
GE Centricity AGFA Impax GE Centricity GE Centricity Fuji Synapse
Tumor measurements workstation
Image Archive & Webserver Database
Images Image
Data Results
DICOM Gateways
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Workflow
TIMC Services• Consultation
• Image Analysis• Image Archival
• Web-based Reporting
Clinical Research Coordinator
Website & Database
Image AnalystRadiologist
Imaging Department
Image Analysts review scans with the
Radiologists
Investigator
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Services• Consultation
• Image Analysis• Image Archival
• Web-based Reporting
Clinical Research Coordinator
Investigator
Image Analyst
TIMC Workflow
Radiologist
Imaging Department
Image Analysts upload
measurements for CRCs & Investigators
to TIMC secure website
Website & Database
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
John Doe
*********
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
TIMC Experience to Date
• 29 trials, 484 scans
• All (but 1 trial) results communicated by web-server
(nearly paperless)
• Accruing one new trial per week on average
• Many new trials now budget for TIMC services
• All studies transferred from Cancer Center Institutions’
PACS (CD-ROM eliminated)
• Revenues to exceed expenses in 2Q/2008
DF/HCCDANA-FARBER / HARVARD CANCER CENTER
DF/HCCMember
Institutions
1 Massachusetts General Hospital (MGH), 2 Brigham and Women’s Hospital (BWH), 3 Dana-Farber Cancer Center (DFCI), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital Boston (CHB), 4 Harvard Medical School (HMS), Harvard School of Public Health (HSPH)
• Electronic signature in compliance with 21 CFR Part 11 Regulations
• Interface to Electronic Data Capture (EDC) systems
• Routine quantitative reporting of tumor measurements as an addendum to clinical reports
• Routine volumetrics to replace RECIST
• Advanced PET metrics to supplement SUVmax
TIMC Future
www.tumormetrics.org
