Technical Note: In silico imaging tools from the VICTRE clinical trial.

Area of Science:

• Medical imaging
• Computational biology
• Regulatory science

Background:

• In silico imaging clinical trials offer a cost-effective and time-efficient alternative to traditional human trials for regulatory evaluation.
• The Virtual Clinical Trial for Regulatory Evaluation (VICTRE) project developed a computational pipeline to replicate traditional trials.

Purpose of the Study:

• To describe the in silico imaging software tools used in the VICTRE project.
• To present a computational pipeline for in silico imaging clinical trials.

Main Methods:

• Development of digital breast models with procedural generation for normal anatomy.
• Insertion of lesions into breast models and simulation of imaging using GPU-accelerated Monte Carlo methods.
• Image interpretation models were used to analyze simulated images for lesion detection.

Main Results:

• An open-source collection of in silico tools for conducting imaging clinical trials was developed.
• All tools and source codes are freely available for public use.

Conclusions:

• The VICTRE project provides open-source tools that facilitate the design and execution of in silico imaging clinical trials.
• The computational pipeline can be utilized as a complete imaging chain, modified for different trial designs, or used as independent components.