- March 14, 2019
- Organized By:
Prior FDA Grand Rounds presentation
Aldo Badano, PhD
Division of Imaging, Diagnostics and Software Reliability
Office of Science and Engineering Laboratories
FDA’s Center for Devices and Radiological Health
The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography
About the Presentation
Can in silico imaging trials play a role in the evaluation of new medical imaging systems? 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.
About the Presenter
Dr. Aldo Badano is Deputy Director of the Division of Imaging, Diagnostics, and Software Reliability in FDA’s Office of Science and Engineering Laboratories. He earned an MEng in Radiological Health Engineering and a PhD in Nuclear Engineering from the University of Michigan in 1999 and 1995 respectively after obtaining a ChemEng from the Universidad de la República, Montevideo, Uruguay in 1992. His primary interests are in the characterization and modeling of medical imaging acquisition and visualization systems. Dr. Badano is the author of more than 300 publications (70 in the last 5 years) cited 2,800 times. Citations including a tutorial book on medical displays. He also leads international consensus development efforts through standards activities. Dr. Badano has significantly contributed to the training of young regulatory scientists and has successfully directed several doctoral theses. He received CDRH's 2018 Supervisory Excellence Award and 2013 Excellence in Mentoring Award, as well as FDA's 2003 Excellence in Laboratory Science Award.