VICTRE AUTOMATIC PIPELINE

Access to VICTRE PIPELINE GitHub repository

Virtual Imaging Clinical Trial for Regulatory Evaluation

Clinical trials are expensive and delay the regulatory evaluation and early patient access to novel devices. In order to demonstrate an alternative approach, a recent effort at the Division of Imaging, Diagnostics, and Software Reliability at the U.S. Food and Drug Administration (known as the VICTRE project) demonstrated the replication of one such clinical trial using completely in-silico tools and compared results in terms of imaging modality performance between the human trial and the computational trial. The VICTRE trial involved imaging approximately 3000 digital breast models in digital mammography and digital breast tomosynthesis system models. On this page we are making all the in silico components of VICTRE freely available to the community.

Citation: “Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial.” Aldo Badano, Ph. D., Christian G. Graff, Ph. D., Andreu Badal, Ph. D., Diksha Sharma, M. Sc., Rongping Zeng, Ph. D., Frank W. Samuelson, Ph. D., Stephen Glick, Ph. D., and Kyle J. Myers, Ph. D. JAMA Network Open. 2018;1(7):e185474; doi:10.1001/jamanetworkopen.2018.5474.

Overview of the VICTRE project 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.

Note: All code is under CC0 (Creative Commons 1.0 Universal License) except for the FBP code that is a derivation of a GPL3 code and remains as GPL3.

VICTRE team: Aldo Badano, Ph. D., Christian G. Graff, Ph. D., Andreu Badal, Ph. D., Diksha Sharma, M. Sc., Rongping Zeng, Ph. D., Aunnasha Sengupta, Miguel A. Lago, Ph. D., Frank W. Samuelson, Ph. D., Stephen Glick, Ph. D., and Kyle J. Myers, Ph. D.

Disclaimer

This software and documentation (the “Software”) were developed at the Food and Drug Administration (FDA) by employees of the Federal Government in the course of their official duties. Pursuant to Title 17, Section 105 of the United States Code, this work is not subject to copyright protection and is in the public domain. Permission is hereby granted, free of charge, to any person obtaining a copy of the Software, to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, or sell copies of the Software or derivatives, and to permit persons to whom the Software is furnished to do so. FDA assumes no responsibility whatsoever for use by other parties of the Software, its source code, documentation or compiled executables, and makes no guarantees, expressed or implied, about its quality, reliability, or any other characteristic. Further, use of this code in no way implies endorsement by the FDA or confers any advantage in regulatory decisions. Although this software can be redistributed and/or modified freely, we ask that any derivative works bear some notice that they are derived from it, and any modified versions bear some notice that they have been modified.

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