Key Elements for Image Exchange. â« Friendly applications. â« Minimum time required for training. â« 24/7 availability to readers. â« Minimal need for on-site ...
Key Elements for Image Exchange Friendly applications Minimum time required for training 24/7 availability to readers Minimal need for on-site personelle availability Ability to accommodate multiple readers High upload and navigation speed Security, compliance Less cost Friendly applications
ACR Clinical Research Center Imaging IT Infrastructure Enables analyses by providing an application for every modality, interconnected by a single infrastructure.
Resources
ACR IT Resources
~ 55 full-time staff in 2 separate offices
Onsite Contractors
Offshore Contractors in Moscow,Russia;n Hyderabad, Kerala India
Vendor Development Partners (e.g.Siemens, Microsoft, Clario Med)
Data Center Facilities
ACR Board of Chancellors
Commission on Clinical Research and IT
IT & Informatics Committee
Subcommittee on Clinical Research (Liaison)
Project Informatics Initiatives
ACRIN RTOG Other
Common Imaging Informatics Infrastructure Other ACR Res. Independent Core Lab Services
ECOG
•Registries •DOD Trials
Common Informatics Infrastructure TRIAD | CTMS | RDC| CTDW | Stat| Data/Network| Support
• Common imaging informatics infrastructure supporting a diverse portfolio of projects • Variety of tools with an emphasis on inter-operability and interconnectivity
Web-access to ACR multiplatform imaging informatics system
Key Elements •Fast and secure upload of DICOM files •In-built customizable deidentification •Fully validated PET/CT dedicated software with GCP compliance •Fast navigation, friendly use but requires training •Latest Citrix Technology for Distributed, Web-based Access •Enables Cross-Platform Delivery (Access from Laptops, PDAs) •Quantification capability (SUVs, MTV etc)
Imaging Informatics Components Site •
TRIAD Site Server (DICOM Gateway) • Local DICOM Routing • Caching/Bulk Submission • Anonymization • HTTPS to Central Office TRIAD Workstation (Rich client) • Ad Hoc Submission • Local Processing • Visualization • Anonymization Thin Client Tools • User/Site administration • Custom Anonymization Profiles • Form Submission
CTMS •System of Record (users, sites) •Web-based data collection,tracking •Image Acquisition and tracking •Over 10 Years in Production •Medidata Rave - Bravo QC/QA Review
Clinical Trial Data Warehouse •Image and metadata archive •283 Studies, 40 DICOM Imaging •Data Extracts & Ad hoc Reporting •Nightly Data Loads
3rd- Party Workstations and Quantitative tools •Viewer and measurement tools •Statistical Analysis
Core Lab
Imaging Applications
PHASE II TRIAL OF RESPONSE-ADAPTED CHEMOTHERAPY BASED ON POSITRON EMISSION TOMOGRAPHY FOR BULKY STAGE I AND II (ECOG 2410) HODGKIN LYMPHOMA
General Rules for E2410 • All PET/CT studies must be electronically sent to the imaging core lab. Imaging core lab should ensure that the sites will be able to perform this task • Readers who agree to participate in the FDG PET/CT’s reading process of this study agree to the terms to ensure no delays in chemotherapy schedules for optimal patient care and to avoid any inconvenience to the participating sites • All post cycle 2 PET/CTs WILL be read within 24 hours of the submission of the study to the reader by the imaging core lab • All PET/CT studies WILL be read within 48 hours of the submission of the study to the reader by the imaging core lab to ensure a 72 hour total turn around time
E2410 STUDY OUTLINE
pool of 7-8 readers
CENTRAL READING turn around per reader 24 hrs Total: 72 hrs
CENTRAL READING
CENTRAL READING
turn around per reader 24 hrs Total: 72 hrs
turn around per reader 24 hrs Total: 72 hrs
Resources
Key Elements for Image Exchange Friendly applications - yes Minimum time required for training – ? 24/7 availability - yes No dependence on site personelle availability - yes Speed - yes Secure - yes Competent - yes Less cost - no
CALGB Imaging Core Lab
Wright Center of Innovation in Biomedical Imaging
Webinar access to core lab imaging informatics system
ICL WebEx - Site Training, Education, Remote Review
Resources
Web-access to ACR platform
Friendly applications yes Time required for training moderate 24/7 availability yes Dependence on site personel no High navigation speed yes Access to multiple readers yes Highly secure yes Less cost no
Webinar CALGB
yes minimum no yes yes no yes yes
PHASE II TRIAL OF RESPONSE-ADAPTED CHEMOTHERAPY BASED ON POSITRON EMISSION TOMOGRAPHY FOR NON-BULKY STAGE I-II (CALGB 50604) AND FOR BULKY STAGE I-II (CALGB 50801) HL A PHASE II TRIAL OF RESPONSE ADAPTED THERAPY OF STAGE III-IV HL USING EARLY INTERIM FDG-PET IMAGING (SWOG 0816)
CALGB 50801 FDG-PET/CT at baseline 2 cycles ABVD
FDG-PET/CT after 2 cycles 8-10 dys after dy-15 dose of ABVD during Cycle 2 (i.e. on dy 23 or 24 or 25 of cycle 2)
PET+
PETACTION 1 1 central reader Completely “-” (grade 1) no action Any grade of “+” go to ACTION 2
ACTION 2 2 central readers Consensus no action if disagreement go to ACTION 3 Turn around 24 hrs
ACTION 3 Adjudication with 1 other central reader FINAL READ Turn around 24 hrs
Turn around 24 hrs
ESCALATED BEACOPP x 4cycles
ABVD 2 more cycles (total of 4 cycles)
Involved field RT
FDG-PET/CT
*PETACTION 1 1 central reader Completely “-” (grade 1) no action Any grade of “+” go to ACTION 2 Turn around 48 hrs
*PET+
*There will be one more PET/CT central read that will be following the same scheme in those patients whose biopsies are deferred. Refer to the study outline (prior slide) for clarification
Biopsy
ACTION 2 2 central readers Consensus no action if disagreement go to ACTION 3
ACTION 3 Adjudication with 1 other central reader FINAL READ
Turn around 48 hrs
Turn around 48 hrs
CALGB 50604 - STUDY OUTLINE
CENTRAL READING turn around per reader 24 hrs Total: 72 hrs
CENTRAL READING turn around per reader 48 hrs Total: 6 dys
CENTRAL READING turn around per reader 48 hrs Total: 6 dys
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