Virtual Clinical Trials for the Assessment of Novel Breast Screening Modalities

Validation of any imaging system is challenging due to the huge number of system parameters that should be evaluated. The ultimate metric of system performance is a clinical trial. However, the use of clinical trials is limited by cost and duration. We are strong proponents of a preclinical alternative, in the form of Virtual Clinical Trials (VCT), which model human anatomy, image acquisition, display and processing, and image analysis and interpretation. A complete VCT pipeline was envisioned by combining the breast anatomy and image acquisition simulation pipeline developed at the University of Pennsylvania, with the MeVIC image display and observation pipeline developed by researchers at Barco. Today an integrated virtual clinical trial design program, VCTdesigner, and a virtual clinical trial management program, VCTmanager, are freely available (www.VCTworld.org). The pipeline design is flexible and extensible, making it possible to add functionality easily and rapidly. It is our hope that by freely distributing the VCTmanager software, our field can standardize on this platform for running VCT.