MammoWave Breast Imaging Device: An International and Multicentric Clinical Investigation

This work presents the first multicentric, single arm, prospective study to evaluate the ability of MammoWave, a microwave imaging prototype, in breast lesions detection. This study was the first breast microwave imaging study during which both symptomatic and asymptomatic subjects were recruited. MammoWave output consists of a selection of microwave images' features, determined prior to the beginning of the trials, to quantify images' non-homogenous behavior. Our results on 382 breasts show a sensitivity of 82% using a statistical significance of p<0.05, indicating MammoWave's ability in distinguishing breasts with and without radiological findings. This prospective clinical trial may pave the way for introducing microwave imaging into clinical practice, for assisting in identification of breast lesions in asymptomatic women of all ages, without safety limitations.