Evaluating Biennial Contrast-Enhanced Mammography Added to Annual 3D Mammography for Breast Cancer Detection in Women With a Personal History of Breast Cancer

What this Trial Is About

Researchers are evaluating whether adding biennial contrast-enhanced mammography CEM to annual 3D mammography digital breast tomosynthesis or DBT improves breast cancer detection while keeping false positives low in women with a personal history of breast cancer. The study aims to see if CEM can maintain or improve cancer detection rates compared to annual DBT alone, potentially finding cancers missed by DBT. This trial is prospective and involves women aged 30 to 79 who have had breast cancer and are at least one year past surgery or treatment. Participants will receive a baseline CEM exam along with their routine annual 3D mammogram, then have follow-up CEM exams at 24 and 48 months after the baseline. Throughout the study, they will continue their usual annual 3D mammograms as part of standard care. Two radiologists will independently review the mammograms and CEM images in different sequences to evaluate detection rates and false positives. During the study, women will attend screening visits to receive their imaging exams and have their results interpreted by radiologists. Researchers will measure how many additional cancers are detected at 24, 48, and 62 months, the rate of false-positive recalls, and the positive predictive value of the combined imaging. The study will monitor participant safety and outcomes over several years, with the total participation lasting at least four years.

Biennial CEM in Women With a Personal History of Breast Cancer