The simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE trial) used computer-simulated imaging of 2,986 in silico patients to compare digital mammography and digital breast tomosynthesis (an advanced form of breast imaging, or mammography, that uses a low-dose x-ray system and computer reconstructions to create three-dimensional images of the breasts).  It found an improved lesion detection performance favoring tomosynthesis for all breast sizes and lesion types. The increased performance of tomosynthesis was consistent with results from a comparative trial using human patients and radiologists. 

The study’s findings suggest that in silico imaging trials and imaging system computer simulation tools can, in some cases, be considered viable sources of evidence for the regulatory evaluation of imaging devices. FDA provides evidence that state-of-the-art computational methods, coupled with laboratory testing, can lead to less burdensome regulatory evaluation approaches.