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|Author(s):||Charles D. Fenimore; Andrew Buckler; P. David Mozeley; Lawrence H. Schwartz; Nicholas Petrick; Michael McNitt-Gray; Kevin O?Donnell; Wendy Hayes; Hyun Kim; Laurence Clarke; Daniel Sullivan;|
|Title:||Volumetric CT in Lung Cancer: An Example for the Qualification of Imaging as a Biomarker|
|Published:||January 09, 2010|
|Abstract:||The Quantitative Imaging Biomarker Alliance (QIBA) has been organized to establish a methodology whereby multiple stakeholders collaborate to test hypotheses about the technical feasibility and the medical value of imaging biomarkers. It has charged the Volumetric Computed Tomography (CT) Technical Subcommittee with investigating the technical feasibility and clinical value of quantifying changes over time in either volume or other parameters. Lung cancer was selected as the first example. Success will be defined as sufficiently rigorous improvements in CT-based outcome measures to (1) allow individual patients in clinical settings to switch treatments sooner if they are no longer responding to their current regimens, and (2) reduce the costs of evaluating investigational new drugs to treat lung cancer. This mechanism is cost-effective for stakeholders while simultaneously advancing the public health by advancing the use of measures which prove effective. If the specific aims are achieved in the example, then the paradigm will be extrapolated to other clinical scenarios where increasingly powerful imaging biomarkers across modalities become medically meaningful.|
|Pages:||pp. 107 - 115|
|Keywords:||quantitative imaging, therapy response, imaging biomarker, volumetric CT, regulatory pathway|
|Research Areas:||Bioscience & Health|
|PDF version:||Click here to retrieve PDF version of paper (1MB)|