RESUMEN
PURPOSE: In silico imaging clinical trials are emerging alternative sources of evidence for regulatory evaluation and are typically cheaper and faster than human trials. In this Note, we describe the set of in silico imaging software tools used in the VICTRE (Virtual Clinical Trial for Regulatory Evaluation) which replicated a traditional trial using a computational pipeline. MATERIALS AND METHODS: We describe a complete imaging clinical trial software package for comparing two breast imaging modalities (digital mammography and digital breast tomosynthesis). First, digital breast models were developed based on procedural generation techniques for normal anatomy. Second, lesions were inserted in a subset of breast models. The breasts were imaged using GPU-accelerated Monte Carlo transport methods and read using image interpretation models for the presence of lesions. All in silico components were assembled into a computational pipeline. The VICTRE images were made available in DICOM format for ease of use and visualization. RESULTS: We describe an open-source collection of in silico tools for running imaging clinical trials. All tools and source codes have been made freely available. CONCLUSION: The open-source tools distributed as part of the VICTRE project facilitate the design and execution of other in silico imaging clinical trials. The entire pipeline can be run as a complete imaging chain, modified to match needs of other trial designs, or used as independent components to build additional pipelines.