Study Comparing Siemens Mammomat B.Brilliant and Revelation Breast Imaging Systems Evaluating Diagnostic Imaging for Suspicious Breast Calcifications in Women

What this Trial Is About

This research aims to evaluate the MAMMOMAT B.brilliant system, a new wide-angle digital breast tomosynthesis imaging device, in women undergoing breast cancer screening with suspicious calcifications. The study compares this novel system to the standard MAMMOMAT Revelation system, both FDA approved, to assess image quality and visibility of calcifications. The study is observational and involves women 18 years or older who require additional diagnostic imaging after screening. Participants will receive standard diagnostic mammography using the same machine as their screening exam, either the MAMMOMAT B.brilliant or the MAMMOMAT Revelation. In addition, they will have two research images taken on the alternate system. The research scans will include compression of the affected breast for 5-8 or 25 seconds in two views to collect data on image quality and calcification visibility. During the study, women will undergo these imaging procedures and may complete patient surveys assessing pain and comfort. Researchers will compare the two imaging systems over an 18-month period, focusing on the accuracy of detecting calcifications and patient experience. All diagnostic decisions will follow standard care protocols. The total study duration for each participant extends to 18 months from enrollment.

B.Brilliant Revelation Comparision Study