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

Abstract

Objectives: Determine the proportion of breast cancers for which MARIA® findings correspond to the cancer, with stratification by breast density and histological type. Investigate performance in symptomatic lesions. Gain patient feedback on experience with MARIA®. Methods: MARIA® uses 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 to 4 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%) malignant lesions showed correspondence between the MARIA® 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. MARIA® scanning was well tolerated. Conclusions: We believe that MARIA® signal corresponds to a malignant lesion in 47% of breast cancers examined. Advances in knowledge: Our study, the largest to date for this type of technology, demonstrates successes and limitations of this MARIA® M6 version.