A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection

Abstract

Microwave imaging is a safe and promising new technology in breast radiology, avoiding discomfort of breast compression and usage of ionizing radiation. This paper presents the first prospective microwave breast imaging study during which both symptomatic and asymptomatic subjects were recruited. Specifically, a prospective multicentre international clinical trial was performed in 2020–2021, to investigate the capability of a microwave imaging device (MammoWave) in allowing distinction between breasts with no radiological finding (NF) and breasts with radiological findings (WF), i.e., with benign or malignant lesions. Each breast scan was performed with the volunteers lying on a dedicated examination table in a comfortable prone position. MammoWave output was compared to reference standard (i.e., radiologic study obtained within the last month and integrated with histological one if available and deemed necessary by responsible investigator) to classify breasts into NF/WF categories. MammoWave output consists of a selection of microwave images’ features (determined prior to trials’ start), which allow distinction between NF and WF breasts (using statistical significance p<0.05). 353 women were enrolled in the study (mean age 51 years ± 12 [SD], minimum age 19, maximum age 78); MammoWave data from the first 15 women of each site, all with NF breasts, were used for calibration. Following central assessor evaluation, 111 NF (48 dense) and 272 WF (136 dense) breasts were used for comparison with MammoWave output. 272 WF comprised 182 benign findings and 90 malignant histology-confirmed cancer. A sensitivity of 82.3% was achieved (95%CI: 0.78–0.87); sensitivity is maintained when limiting the investigation to histology-confirmed breasts cancer only (90 histology-confirmed breasts cancer have been included in this analysis, having sizes ranging from 3 mm to 60 mm). Specificity value of approximately 50% was achieved as expected, since thresholds were calculated (for each feature) using median value obtained after recruiting the first 15 women (of each site), all NF. This prospective trial may represent another step for introducing microwave imaging into clinical practice, for helping in breast lesion identification in asymptomatic women.

Deep Learning in Breast Cancer Imaging: State of the Art and Recent Advancements in Early 2024

“…Moreover, at present time microwave imaging seems to have some performance limitations compared to mammography. A recent multicentric, single-arm, prospective, stratified clinical investigation evaluated a commercial microwave imaging system's ability to detect breast lesions, demonstrating overall worse accuracy when compared to a reference standard (73%) [118].…”

Dielectric Characterization of Breast Biopsied Tissues as Pre-Pathological Aid in Early Cancer Detection: A Blinded Feasibility Study

“…This approach aims to provide valuable information to pathologists, enabling them to prioritize samples for further analysis through standard histological assessment. The study involves the dielectric characterization of 64 biopsy samples obtained from 15 patients at Complejo Hospitalario Universitario de Toledo, Spain, in the framework of a multicentric study to evaluate a new microwave-based imaging device, MammoWave (UBT Srl, Rivotorto, Perugia, Italy) [ 36 , 37 ]. By employing a blind experimental methodology, where both pathologists and radiologists are unaware of the dielectric characterization results, we can accurately assess the effectiveness of our classification method in facilitating early breast cancer detection.…”