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

Abstract

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.