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

Autor: Sánchez-Bayuela DÁ; UBT-Umbria Bioengineering Technologies, Perugia, Italy.; Breast Imaging Department, Radiology Service, Complejo Hospitalario Universitario de Toledo, Spain.; Faculty of Chemical Science and Technology, Instituto Regional de Investigación Científica Aplicada, University of Castilla, La Mancha, Spain., Ghavami N; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Tiberi G; UBT-Umbria Bioengineering Technologies, Perugia, Italy.; School of Engineering, London South Bank University, London, United Kingdom., Sani L; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Vispa A; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Bigotti A; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Raspa G; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Badia M; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Papini L; UBT-Umbria Bioengineering Technologies, Perugia, Italy., Ghavami M; School of Engineering, London South Bank University, London, United Kingdom., Castellano CR; Breast Imaging Department, Radiology Service, Complejo Hospitalario Universitario de Toledo, Spain., Bernardi D; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.; Humanitas University, Milan, Italy., Calabrese M; IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Tagliafico AS; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.; University of Genoa, Genoa, Italy.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Jul 14; Vol. 18 (7), pp. e0288312. Date of Electronic Publication: 2023 Jul 14 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0288312
Abstrakt: 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.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Navid Ghavami, Gianluigi Tiberi, Lorenzo Sani, Alessandro Vispa, Alessandra Bigotti, Giovanni Raspa and Mario Badia, are employed by UBT - Umbria Bioengineering Technologies Srl. Navid Ghavami, Gianluigi Tiberi and Lorenzo Sani are shareholders of UBT - Umbria Bioengineering Technologies. Please NOTE that the authors listed had no access to "reference standard" (only the Local Investigators and the C.R.O. had access to "reference standard"). UBT manufactured the microwave imaging device known as MammoWave. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2023 Sánchez-Bayuela et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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