Difference between revisions of "UPICT"
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The following documents are works in progress. Your input and feedback is invited. However, we do not recommend the use of these in-progress protocols in clinical trials or other applications. | The following documents are works in progress. Your input and feedback is invited. However, we do not recommend the use of these in-progress protocols in clinical trials or other applications. | ||
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===CT Protocols=== | ===CT Protocols=== | ||
Revision as of 21:26, 12 July 2012
UPICT Concept:
To facilitate the development and maintenance of widely acceptable, consistent imaging protocols (including imaging quality control procedures) for use in clinical trials across a range of disease states, anatomic sites, and imaging modalities:
- to “improve” the contribution of imaging data in clinical trials, including improved statistical power while supporting robust case accrual and decreasing time to study initiation / site activation
- to facilitate image data aggregation across trials
- to allow the development, optimization, and validation of imaging biomarkers through the participation of imaging scientists and clinical trialists drawn from the broad range of interested constituencies
UPICT Goals:
- Reduce variance related to imaging in the conduct of clinical trials (early and late phase so as to support both translation and clinical indications):
– to allow the detection of differences that are a consequence of the intervention under study, not an artifact of the manner in which the imaging is conducted – to support optimization and validation of imaging biomarkers (platforms, agents, algorithms, etc.)
- Improve the likelihood that:
– clinical imaging studies obtained will comply with clinical trial protocol expectations – clinical trial imaging protocols will “fit” with practice
- Potentially provide a subtle impetus to improve standard of care (thereby increasing the chances that pre-enrollment imaging might be used as “baseline” study)
UPICT Objectives:
- Short term
– standard imaging protocol template(s) – a web-based workspace and supporting infrastructure to facilitate the submission, vetting, and annotation of Proffered Protocols in a transparent and inclusive manner – a web-based resource library of annotated Proffered Protocols that have been used to support clinical trials within institutions, cooperative groups, and trials consortia that meet a minimum set of criteria – a web-based workspace and infrastructure to facilitate the iterative authoring and periodic review of Consensus Protocols in a transparent and inclusive manner – a web-based environment to facilitate the interaction among clinical trialists and imaging scientists within academia, industry, and agencies
- Long(er) term
– a web-based resource library of Consensus Protocols that have been subjected to rigorous, transparent, inclusive (yet expert) review and approval that will be updated through an ongoing process
UPICT Process and Template
Workspace and Template Extractions in Progress
- The Workspace is used to facilitate the submission,vetting and annotation of Proffered Protocols and the iterative authoring and periodic review of Consensus Protocols in a transparent and inclusive manner.
- The outline form of the generic Template is posted.
- Web-based workspace and supporting infrastructure; multiple options are available
- The current work on template extractions is available here.
Draft Proffered Protocols
Draft Proffered Protocols are in-progress documents that will lead to new Proffered Protocols once the Normalization Process is complete.
The following documents are works in progress. Your input and feedback is invited. However, we do not recommend the use of these in-progress protocols in clinical trials or other applications.
CT Protocols
- CT Reference Material
- CT Archive
MR Protocols
- MR Reference Material
PET Protocols
A. Oncologic FDG-PET Protocol
- FDG-PET Multiextract
UPICT FDG multiextract.doc posted post-call 06.02.10
- FDG-PET Consolidated Consensus
FDG-PET/CT: UPICT_FDG_Consolidated Statement, post call 08.10.2011 posted 8.10.2011
B. Alzheimer's Disease PET
- Alzheimer's Disease PET Proffered Protocols
- Alzheimer's Disease PET Reference Material
| Submission Process | Normalization Process | Consensus Process | ||||||
| Submitted Protocols | > | Draft Proffered Protocols | > | Proffered Protocols | > | Draft Consensus Protocols | > | Consensus Protocols |
|---|---|---|---|---|---|---|---|---|