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
- 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)
- 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:
UPICT publishes protocols in a standardized UPICT template.
The Normalization Process involves:
- taking a Submitted Protocol as raw material
- emailing interested community members to sign up to participate in normalization
- assigning an editorial team (3) with team leader and due dates
- creating Draft Proffered Protocols by copying the submitted material into the UPICT Template
- ideally the protocol has been submitted in the UPICT Template
- cleaning up and clarifying the document
- the editorial process cannot substantively alter the imaging protocol
- editorial comments and instructive “boilerplate” language may be inserted
- annotating the protocol with metatags to facilitate searching
- notifying community members and the protocol donor to allow 30-days for comment on the Draft Proffered Protocol
- adjudicating any comments by WebEx if necessary
- publishing the protocol in the Proffered Protocols section of the UPICT Library with appropriate (new) disclaimer
The steps and work products of the UPICT Process can be summarized as:
|Submission Process||Normalization Process||Consensus Process|
|Submitted Protocols||>||Draft Proffered Protocols||>||Proffered Protocols||>||Draft Consensus Protocols||>||Consensus Protocols|
Workspace and UPICT 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 UPICT Template is posted.
- Web-based workspace and supporting infrastructure; multiple options are available
- The current work on template extractions is available here: http://qibawiki.rsna.org/index.php?title=Draft_Proffered_Protocols
The UPICT Library (under development) will provide centralized, public access to a pool of protocols for use in Clinical Trials.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan; 45(2):228-47.
Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1:122S-50S. J Nucl Med. 2009 May;50 Suppl 1:122S-50S.
UPICT poster RSNA 2010 annual meeting
UPICT poster RSNA 2009 annual meeting
UPICT Working Groups