Science & Education
PROFILE IMPLEMENTATION FEEDBACK PROCESSCurrent Profiles Under Development
Note to users - when referencing the above QIBA Profile documents, please use the following format:Specific QIBA Tech Ctte. * Specific Profile Title, * Quantitative Imaging Biomarkers Alliance. * Version. * Profile Stage. * QIBA, * Date. * Available from: URLFormat example: DCE-MRI Technical Committee. DCE-MRI Quantification Profile, Quantitative Imaging Biomarkers Alliance. Version 1.0. Reviewed Draft. QIBA, July 1, 2012. Available from: RSNA.ORG/QIBA What is a QIBA Profile?A Profile is a document used to organize and record the results of the collaborative work by QIBA participants.
A Profile is a document used to organize and record the results of the collaborative work by QIBA participants.
A Profile consists of one or more Claims and associated Details.
The process specifies what to achieve, rather than how to achieve it. For each biomarker, QIBA Modality Committees initially determine what Profiles to pursue and what key scientific precursor questions and concepts need validation. The Committee then coordinates the research and consensus discussions to achieve resolution of the issues. This diagram illustrates the inter-related activities which are pursued in Profile development.
The goal is to establish processes and Profiles that will lead to acceptance of quantitative imaging biomarkers by the imaging community, clinical trial industry, and regulatory agencies as proof of biology, proof of changes in pathophysiology, and surrogate end-points for changes in the health status of patients. The process addresses obstacles faced by suppliers seeking to commercialize imaging biomarker tests. This should lead to wider availability and utilization of these imaging biomarkers.
The clinical context is defined by ad-hoc sub-committees of treating physicians, radiologists, and medical physicists who start by defining the clinical context (e.g., disease staging, clinical manifestations, etc.), determine what biomarkers to pursue, and then for each biomarker, determine what Profiles to pursue.
Profile claims are defined by the ad-hoc disease sub-committees, by characterizing the currently accepted standard (e.g., RECIST), stating how the new imaging biomarker will do better, and adopting a statistically rigorous framework. The results are recorded in the Profile that outlines the various claims made for the new biomarker, both in terms of science as well as supporting issues such as interoperability or system support issues relevant to the performance of the biomarker.
Examples: Claim #1 (CT volumetry): A measured volume change of more than 30% for a tumor provides at least a 95% probability that there is a true volume change; P(true volume change > 0% | measured volume change >30%) > 95%.
Claim #2 (DCE-MRI): Quantitative microvascular properties, specifically transfer constant (Ktrans) and blood-normalized initial-area-under-the-gadolinium-concentration curve (IAUGCBN), can be measured from DCE-MRI data obtained at 1.5T using low-molecular-weight extracellular gadolinium-based contrast agents with a 20% within-subject coefficient of variation for solid tumors at least 2 cm in diameter. GROUNDWORK
Groundwork activities include but are not limited to:
Profile Details bring together the results of the previous three activities (i.e., statements of Clinical Context, Profile Claims and Groundwork), to specify what must be done in order to achieve the claim, based on the groundwork and for a given clinical context.
SUMMARY of COLLABORATIVE ACTIVITY
What is a QIBA Protocol?
A QIBA Protocol is an imaging protocol developed in conjunction with a QIBA Profile, and which follows the UPICT template and conventions. QIBA Protocols describe how clinical trial subjects or patients should be imaged so as to achieve reproducible quantitative endpoints when those tests are performed utilizing systems that meet the specific performance claims stated in the QIBA Profiles.
The 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
Links to Protocols may be found on the QIBA WIKI at: http://qibawiki.rsna.org/index.php?title=Submitted_Protocols
The UPICT Library (under development) provides centralized, public access to a pool of protocols for use in Clinical Trials. For more information on UPICT, please visit the QIBA WIKI at: http://qibawiki.rsna.org/index.php?title=UPICT