Results for the London investigation into dielectric scanning of lesions study of the MARIA? M6 breast imaging system

Objectives: Determine the proportion of breast cancers for which MARIAV (R) findings correspond to the cancer, with stratification by breast density and histological type. Investigate performance in symptomatic lesions. Gain patient feedback on experience with MARIAV (R). Methods: MARIA (R) Ruses a radio frequency antennae array to measure signal attenuation and back scatter to build up a 3D map of tissue dielectric values. The study was a prospective, single-centre, interventional, post-approval device study. Recruitment: Patients were eligible if they were attending symptomatic breast clinic or had confirmed or suspected breast cancer from any referral source. Recruitment between May 2018 and March 2020. Reading: Regions of higher signal compared to background or distinct by shape were considered candidates for lesion correspondence. Up to4 candidate regions per breast were annotated in likelihood order for representing a true lesion. Results:389 patients were recruited, and 6 excluded. 114 patients recruited with breast cancers (2 bilateral, 5 multicentric). 57 (47%) malignantlesions showed correspondence between the MARIAV (R) signal and the cancer. Higher correspondence was seen in invasive (50%) than in situ(29%) disease. There was no reduction in correspondence at higher breast density. Reduced signal correspondence in the central scan volume and for small lesions. MARIAV (R) scanning was well tolerated. Conclusions: We believe that MARIAV (R) signal corresponds to a malignant lesion in 47% of breast cancers examined.