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The Cancer Imaging Archive

VICTRE | The VICTRE Trial: Open-Source, In-Silico Clinical Trial For Evaluating Digital Breast Tomosynthesis

DOI: 10.7937/TCIA.2019.ho23nxaw | Data Citation Required | Image Collection

Location Species Subjects Data Types Cancer Types Size Supporting Data Status Updated
Breast Human 2,994 MG Breast Cancer 1.03TB Software/Source Code Public, Complete 2019/03/08


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.

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. A 1-hour summary presentation of the project and findings was given at the FDA Grand Rounds on 3/14/2019 and can be found here.

A systematic exploration of the trial parameters including lesion types and sizes is also possible and greatly facilitated by the availability of open-source, free software tools available at

Data Access

Version 1: Updated

Title Data Type Format Access Points Subjects Studies Series Images License
Download requires NBIA Data Retriever
2,994 8,749 8,749 217,913 CC BY 3.0

Additional Resources for this Dataset

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Citations & Data Usage Policy

Data Citation Required: Users must abide by the TCIA Data Usage Policy and Restrictions. Attribution must include the following citation, including the Digital Object Identifier:

Data Citation

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:  10.7937/TCIA.2019.ho23nxaw .

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Publication Citation

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.

TCIA Citation

Clark, K., Vendt, B., Smith, K., Freymann, J., Kirby, J., Koppel, P., Moore, S., Phillips, S., Maffitt, D., Pringle, M., Tarbox, L., & Prior, F. (2013). The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository. In Journal of Digital Imaging (Vol. 26, Issue 6, pp. 1045–1057). Springer Science and Business Media LLC.