Integrating clinical research in an operative screening and diagnostic breast imaging department: First experience, results and perspectives using microwave imaging.

Clinical research is crucial for evaluating new medical procedures and devices. It is important for healthcare units and hospitals to minimize the disruptions caused by conducting clinical studies; however, complex clinical pathways require dedicated recruitment and study designs.This work presents the effective introduction of novel microwave breast imaging (MBI), via MammoWave apparatus, into the clinical routine of an operative screening and diagnostic breast imaging department for conducting a multicentric clinical study. Microwave breast imaging, using MammoWave apparatus, was performed on volunteers coming from different clinical pathways. Clinical data, comprising demographics and conventional radiologic reports (used as reference standard), was collected; a satisfaction questionnaire was filled by every volunteer. Microwave images were analyzed by an automatic clinical decision support system, which quantified their corresponding features to discriminate between breasts with no relevant radiological findings (NF) and breasts with described findings (WF). Conventional breast imaging (DBT, US, MRI) and MBI were performed and adapted to assure best clinical practices and optimum pathways. 180 volunteers, both symptomatic and asymptomatic, were enrolled in the study. After microwave images' quality assessment, 48 NF (15 dense) and 169 WF (88 dense) breasts were used for the prospective study; 48 (18 dense) breasts suffered from a histology-confirmed carcinoma. An overall sensitivity of 85.8 % in breasts lesions' detection was achieved by the microwave imaging apparatus. An optimum recruitment strategy was implemented to assess MBI. Future trials may show the clinical usefulness of microwave imaging, which may play an important role in breast screening. [Abstract copyright: © 2023 The Authors.

MammoWave Breast Imaging Device: A Procedure for Device’s Characterization Via Phantom Measurements and Subsequent Clinical Trials’ Preliminary Results

The use of microwave imaging for breast cancer detection has witnessed growing attention from researchers around the globe. In the past decade, a number of microwave imaging prototypes have completed the preliminary experimental stages and reached clinical trials. This paper presents the machine characterization and preliminary clinical trial results of MammoWave, a dedicated radar-based microwave imaging system for breast lesion detection. MammoWave uses a Huygens principle-based algorithm, operates in air, using two antennas without requiring matching liquids. Our clinical trial results on 102 breasts from 64 patients indicate MammoWave’s ability to distinguish between breasts with and without radiological findings, with a sensitivity of 88%. Significantly, when considering dense breasts only, the sensitivity does not decrease