Can in silico imaging trials play a role in the evaluation of new medical imaging systems? FDA's March 14 Grand Rounds reveals all

To the VICTRE belong the spoils! An in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography

Thursday, March 14, 2019

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

 

Presented by 

Aldo Badano, PhD

Deputy Director

Division of Imaging, Diagnostics and Software Reliability

Office of Science and Engineering Laboratories

FDA’s Center for Devices and Radiological Health

About the Presentation

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.

From this FDA Engineer you’ll learn about:

• The potential for computational models to minimize the need for trials using human patients and medical practitioners
• Current state-of-the-art of computational modeling of radiation medical imaging systems