Comparison of Contrast-Enhanced Mammography versus MRI and Digital Mammography for Screening High-Risk Women for Breast Cancer: The Con-trust Randomized Controlled Trial

What this Trial Is About

Researchers are studying women at high risk of breast cancer, specifically those with a greater than 5% risk over the next five years, aged 35 to 60. The study aims to compare contrast-enhanced mammography (CEM) with the current standard of annual magnetic resonance imaging (MRI) combined with digital mammography (DM) to see if CEM can be a less expensive and quicker alternative for breast cancer detection. The trial will enroll about 1400 women and monitor breast cancer incidence and recall rates over two screening rounds, with a follow-up period of 2.5 years. Secondary goals include evaluating screening performance, safety, and patient compliance, with findings contributing to European breast cancer screening guidelines. Participants will be randomly assigned to receive two rounds of either CEM or MRI+DM surveillance. After two years, all participants will undergo a final standard screening test used for high-risk women at their center. Imaging and assessments are timed with menstrual cycle phases for accuracy. Women unable to tolerate MRI or with specific genetic mutations may be assigned directly to one of the screening methods. Positive findings during screening may lead to further tests like ultrasound-guided biopsies or vacuum-assisted biopsies, with multidisciplinary review and follow-up. The study also includes quality control of imaging equipment, radiation dose monitoring, and retrospective image analysis. During the study, women will have regular visits every 12 months for screening and follow-up assessments. Imaging results will be interpreted locally by experienced radiologists, and additional ultrasound may be used as needed. Researchers will collect data on breast density, radiation exposure, adverse events, and recall rates. Advanced machine learning models will analyze images and clinical data to improve breast cancer risk prediction. The trial also involves cost and organizational impact studies, patient interviews, and systematic reviews to inform future screening guidelines. The total participation time includes two years of screening plus follow-up, with safety and efficacy outcomes measured at 12, 24, and up to 50 months.

Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial