Study to Confirm MammoWaves Ability to Detect Breast Lesions Using Microwave Imaging in Adult Women

What this Trial Is About

Researchers are evaluating the ability of MammoWave, an innovative microwave mammogram device, to detect breast lesions in women. This investigation is multicentric, prospective, single-arm, and stratified by breast density. MammoWave uses very low power microwaves instead of traditional x-rays, making it safe for use at any age, including during pregnancy, and allows repeated exams without ionizing radiation exposure. The study aims to confirm MammoWaves effectiveness in detecting both malignant and benign breast lesions, including palpable, non-palpable, and microcalcifications. The study will enroll up to 600 participants across several centers in Italy, Germany, and Spain. It includes two phases a preliminary phase to optimize the imaging algorithm by examining volunteers without lesions, followed by the main phase enrolling women with and without breast lesions. All participants will undergo the MammoWave exam while lying prone on the device, which takes about 10 minutes per breast. The exam includes image acquisition and data processing to generate images and parameters describing breast tissue. Participants will have a standard breast screening alongside the MammoWave exam. Researchers will assess MammoWaves sensitivity and specificity compared to standard diagnostic methods, including mammography, ultrasound, and MRI. Patient satisfaction will also be measured through questionnaires. The primary outcome is the number of true positive results during the MammoWave procedure. The study began in January 2023 and is expected to continue until January 2027, with ongoing monitoring and comparison of results.

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