UPICT

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

Project Snapshot

This writing group,Uniform Protocols for Imaging in Clinical Trials (UPICT) Alzheimer’s/Dementia (AD) Imaging Protocol Writing Group,is part of the broader UPICT effort - the focus of which is to define standardized imaging protocols for use in clinical trials. UPICT’s goal is to improve the likelihood that data derived from imaging studies performed during clinical trials are reflective of the pathophysiologic processes of interest rather than being secondary to artifacts attributable to variance in the performance and analyses of the imaging. UPICT is sponsored in part by a multi-institutional grant program of the National Institutes of Health (the Clinical and Translational Science Awards or CTSA) in partnership with the Radiological Society of North America (RSNA).

As part of the UPICT process, our Writing Group’s goal is to define a consensus standard MR image acquisition protocol for use in AD clinical trials. Our initial objective is to define an image acquisition protocol for volumetric and safety MRI at 1.5T.

Patricia E. Cole, PhD, MD, (Chair: UPICT Alzheimer’s/Dementia (AD) Imaging Protocol Writing Group)