MR (Diffusion-Weighted Imaging (DWI) of the Apparent Diffusion Coefficient (ADC), Clinically Feasible Profile
Abstract
The goal of a QIBA Profile is to help achieve a useful level of performance for a given biomarker. The Claim (Section 2) describes the biomarker performance and is derived from the body of scientific literature meeting specific requirements, in particular test-retest studies. The Activities (Section 3) contribute to generating the biomarker. Requirements are placed on the Actors that participate in those activities as necessary to achieve the Claim. Assessment Procedures (Section 4) for evaluating specific requirements are defined as needed to ensure acceptable performance. Diffusion-Weighted Imaging (DWI) and the Apparent Diffusion Coefficient (ADC) are being used clinically as qualitative (DWI) and quantitative (ADC) indicators of disease presence, progression or response to treatment. Use of ADC as a robust quantitative biomarker with finite confidence intervals places additional requirements on Sites, Acquisition Devices and Protocols, Field Engineers, Scanner Operators (MR Technologists, Radiologists, Physicists and other Scientists), Image Analysts, Reconstruction Software and Image Analysis Tools. Additionally, due to the intrinsic dependence of measured ADC values on biophysical tissue properties, both the Profile Claims and the associated scan protocols (Section 3.6.2) are organ-specific. All of these are considered Actors involved in Activities of Acquisition Device Pre-delivery and Installation, Subject Handling, Image Data Acquisition, Reconstruction,…
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