Micrima Ltd.

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®.

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.

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.

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.

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.

We believe that MARIA® signal corresponds to a malignant lesion in 47% of breast cancers examined.

Our study, the largest to date for this type of technology, demonstrates successes and limitations of this MARIA® M6 version.

The MARIA^® breast imaging system is a clinical diagnostic tool that uses a hemispherical array of radiowave antennas to generate three-dimensional images of the internal breast. The system utilises the variance of dielectric contrast within the breast volume in order to identify areas of interest for further diagnostic investigation. This multicentre study of 225 patients was conducted at three trial sites and recruited women with both malignant and benign lesions. The MARIA^® images from the study were read by both clinicians who had access to the patient's clinical information, as well as by 'blind' reviewers who did not. Results from the study show an overall sensitivity of 76% for the system, which was similar across benign and malignant findings, and in denser breasts. The results from this study are outlined here and discussions on ongoing and future work with MARIA^® are deliberated.

A microwave imaging system has been developed as a clinical diagnostic tool operating in the 3- to 8-GHz region using multistatic data collection. A total of 86 patients recruited from a symptomatic breast care clinic were scanned with a prototype design. The resultant three-dimensional images have been compared "blind" with available ultrasound and mammogram images to determine the detection rate. Images show the location of the strongest signal, and this corresponded in both older and younger women, with sensitivity of [Formula: see text], which was found to be maintained in dense breasts. The pathway from clinical prototype to clinical evaluation is outlined.