Clinical Investigation to Confirm MammoWave Microwave Mammogram Ability in Detecting Breast Lesions in Women A Multicenter, Single Arm, Prospective Study

What this Trial Is About

Researchers are evaluating the MammoWave, an innovative microwave mammogram device, to confirm its ability to detect breast lesions. This multicentric, single-arm, prospective study focuses on women with breast cancer or benign breast lesions, stratified by breast density. MammoWave uses very low power microwaves to create images without ionizing radiation, making it safe for use at any age and any condition, including pregnancy and specific illnesses. Participants will undergo the MammoWave exam, which takes about 10 minutes. The exam is performed with the patient lying face down in a comfortable prone position, with the breast placed in a special container cup within the device. The exam includes an acquisition phase where microwave data is collected followed by data processing through an integrated imaging algorithm, producing images and related parameters. The study includes two phases: a preliminary phase to optimize the imaging algorithm with volunteers having no lesions, and a second phase where patients with breast lesions will be examined and compared to standard clinical diagnosis. During the study, participants will have a short visit that includes a qualitative assessment of breast density. The MammoWave exam results will be compared with previous radiological studies and histological findings when available. Researchers will measure MammoWave's sensitivity in detecting breast lesions, tracking the number of true positive results. The study involves multiple sites in Italy, Germany, and Spain and plans to enroll up to 600 participants.

A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection