A total of 2986 subjects, with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm, were simulated and imaged on in-silico versions of DM and DBT systems using fast Monte Carlo x-ray transport. Images were interpreted by a computational reader detecting the presence of lesions. The in-silico trial (VICTRE) was designed to replicate a comparative trial from a previous regulatory submission. The endpoint was the difference in area under the receiver-operating-characteristic curve between modalities (delta-AUC) for lesion detection. Using a fully-crossed design, VICTRE was sized for a standard error (SE) of 0.01 in delta-AUC, half the uncertainty seen in the comparative trial.
Expensive and lengthy clinical trials delay regulatory evaluation of innovative medical technologies affecting patient access to high-quality medical products. Sophisticated simulation tools are increasingly being used in device development, but are rarely used in regulatory applications. We investigate a new paradigm for evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM), using exclusively in-silico methods.
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Please be sure to include the following citations in your work if you use this data set:
Badano A, Graff CG, Badal A, Sharma D, Zeng R, Samuelson FW, Glick S, Myers KJ. The VICTRE Trial: Open-Source, In-Silico Clinical Trial for Evaluating Digital Breast Tomosynthesis. 2018. DOI: Coming Soon.
Badano A, Graff CG, Badal A, Sharma D , Zeng R, Samuelson FW, Glick SJ, Myers KJ. Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial. JAMA Netw Open. 2018;1(7):e185474. doi:10.1001/jamanetworkopen.2018.5474. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2717000
Clark K, Vendt B, Smith K, Freymann J, Kirby J, Koppel P, Moore S, Phillips S, Maffitt D, Pringle M, Tarbox L, Prior F. The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository, Journal of Digital Imaging, Volume 26, Number 6, December, 2013, pp 1045-1057. (paper)
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