04 Dec Computer Simulation Study Favors Tomosynthesis over Digital Mammography
MedicalResearch.com Interview with:
Aldo Badano, Ph.D.
Deputy Director, Division of Imaging, Diagnostics, and Software Reliability
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health Silver Spring, MD 20993
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Although computational modeling is increasingly being used in product development, it is rarely at the center of regulatory applications.
Within this context, the VICTRE project attempted to replicate a previously conducted imaging clinical trial using only computational models. The VICTRE trial involved no human subjects and no clinicians. All trial steps were conducted in silico. The fundamental question the article addresses is whether in silico imaging trials are at a mature development stage to play a significant role in the regulatory evaluation of new medical imaging systems. The VICTRE trial consisted of in silico imaging of 2986 virtual patients comparing digital mammography (DM) and digital breast tomosynthesis (DBT) systems.
The improved lesion detection performance favoring DBT for all breast sizes and lesion types was consistent with results from a comparative trial using human patients and radiologists.
MedicalResearch.com: What should readers take away from your report?
Response: The results of the VICTRE trial are consistent with the performance seen in the comparative trial using human subjects and human image interpreters. While further research is needed to assess the generalizability of the findings, the work reported in this article provides evidence that state-of-the-art computational methods can lead to less burdensome regulatory evaluation approaches.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Future research on in silico imaging clinical trials needs to address the limitation of the VICTRE study including improved descriptions of the image interpretation processes. In addition, a systematic exploration of the trial parameters including lesion types and sizes is now possible and greatly facilitated by the availability of open-source, free software tools (see https://github.com/DIDSR/VICTRE).
MedicalResearch.com: Is there anything else you would like to add?
Response: It is important to note that the all–in silico approach for conducting imaging trials is not intended to replace but rather complement or minimize traditional clinical trials. Incrementally incorporating computational results in regulatory submissions can, for example, help decrease the human trial size and length.
Badano A, Graff CG, Badal A, et al. Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial. JAMA Netw Open. 2018;1(7):e185474. doi:10.1001/jamanetworkopen.2018.5474
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