![]() ![]() The change in AUC was larger for masses (mean, 0.0903 ) than for calcifications (mean, 0.0268 ), which was consistent with the findings of the comparative trial (mean, 0.065 for masses and −0.047 for calcifications).Ĭonclusions and Relevance The results of the simulated VICTRE trial are consistent with the performance seen in the comparative trial. Results In this trial, computational readers analyzed 31 055 DM and 27 960 DBT cases from 2986 virtual patients with the following Breast Imaging Reporting and Data System densities: 286 (9.6%) extremely dense, 1200 (40.2%) heterogeneously dense, 1200 (40.2%) scattered fibroglandular densities, and 300 (10.0%) almost entirely fat. ![]() The trial was sized for an SE of 0.01 in the change in area under the curve (AUC), half the uncertainty in the comparative clinical trial. Main Outcomes and Measures The trial end point was the difference in area under the receiver operating characteristic curve between modalities for lesion detection. A positive cohort contained a digitally inserted microcalcification cluster or spiculated mass. A total of 2986 synthetic image–based virtual patients with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm were generated using an analytic approach in which anatomical structures are randomly created within a predefined breast volume and compressed in the craniocaudal orientation. Images obtained with in silico versions of DM and DBT systems via fast Monte Carlo x-ray transport were interpreted by a computational reader detecting the presence of lesions. Objectives To conduct a computer-simulated imaging trial evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM) and to compare the results with a comparative clinical trial.ĭesign, Setting, and Participants The simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) trial was designed to replicate a clinical trial that used human patients and radiologists. Simulation is increasingly being used in product development but rarely in regulatory applications. Importance Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment. ![]() Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography. ![]()
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