A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave in a Population-based Screening Program for Early Breast Cancer Detection

What this Trial Is About

Researchers are evaluating MammoWave, a device that uses low-power microwaves instead of X-rays, for early breast cancer detection in women aged 45 to 74. This prospective, multicenter clinical investigation aims to confirm that MammoWave achieves sensitivity greater than 75 and specificity greater than 90 for breast cancer detection among 10,000 volunteers undergoing regular screening programs. The study compares MammoWave results with conventional breast examination methods including mammograms and other radiological or histological tests. Participants will undergo both the standard breast screening exams and the MammoWave exam. The MammoWave exam involves lying prone on a bed while the device collects microwave data from both breasts over about 8 minutes. Data processing uses a special imaging algorithm to produce microwave images and classification results indicating suspicious or non-suspicious findings. The study device contains the same hardware as a CE-marked version but uses updated software. During the study, participants will have conventional breast exams along with the MammoWave exam. Researchers will evaluate MammoWaves sensitivity and specificity during the procedure and analyze detection rates, recall rates, and positive predictive values at baseline. Volunteers will also complete satisfaction questionnaires. The study will monitor breast cancer detection by histological type, size, and breast density. The trial is expected to run until December 2026.

A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection