Author Interviews, FDA, JAMA, Medical Imaging / 04.12.2018

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 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. 
Author Interviews, Breast Cancer, Radiology, Yale / 30.07.2013

MedicalResearch.com Interview with Dr. Brian Haas MD Department of Diagnostic Radiology,Yale University School of Medicine, New Haven, CT Dr. Brian Haas MD Department of Diagnostic Radiology,Yale University School of Medicine, New Haven, CT MedicalResearch.com: What are the main findings of the study? Dr. Haas: We found that tomosynthesis helped to reduce the number of women who undergo a screening mammogram and are called back for additional imaging and testing. Specifically, the greatest reductions in patients being called back were seen in younger patients and those with dense breasts. Tomosynthesis is analogous to a 3D mammogram, and improves contrast of cancers against the background breast parenchyma.
Author Interviews, Breast Cancer, Cancer Research, Radiology, Yale / 01.07.2013

MedicalResearch.com Interview with: Sarah H. O'Connell M.D. PGY-4 Yale New Haven Hospital Yale School of Medicine Department of Diagnostic Radiology MedicalResearch.com:  What are the main findings of the study? Answer: The purpose of our study was to evaluate the visibility of cancers in women at high-risk for breast cancer on 2D mammography compared to digital breast tomosynthesis. In other words, how would the use of tomosynthesis contribute to cancer visualization in this population  of patients? We evaluated the cancers seen in both high-risk patients, those with a >20% lifetime risk of breast cancer, and intermediate risk  patients, those with a 15-20% lifetime risk of breast cancer, for a total of 56 cancers. We found that 41% (23/56) cancers were better seen on tomosynthesis and 4% (2/56) were only seen on tomosynthesis. The majority of the cancers seen better or only on tomosynthesis  presented as masses rather than as calcifications alone which were better seen on 2D mammography.