A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
Journal article
Ghavami, M., Ghavami, N., Tiberi, G., Alvarez Sánchez-Bayuela, D., Badia, M., Romero Castellano, C., Calabrese, M. and Tagliafico, A. (2023). A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection. PLoS ONE. 18 (7), p. e0288312. https://doi.org/10.1371/journal.pone.0288312
| Authors | Ghavami, M., Ghavami, N., Tiberi, G., Alvarez Sánchez-Bayuela, D., Badia, M., Romero Castellano, C., Calabrese, M. and Tagliafico, A. |
|---|---|
| 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. |
| Keywords | Microwave Breast Imaging; Breast Cancer Detection; Breast Cancer Screening |
| Year | 2023 |
| Journal | PLoS ONE |
| Journal citation | 18 (7), p. e0288312 |
| Publisher | Public Library of Science (PLoS) |
| ISSN | 1932-6203 |
| Digital Object Identifier (DOI) | https://doi.org/10.1371/journal.pone.0288312 |
| Web address (URL) | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0288312 |
| Publication dates | |
| Online | 14 Jul 2023 |
| Publication process dates | |
| Accepted | 25 Jun 2023 |
| Deposited | 20 Jul 2023 |
| Publisher's version | License File Access Level Open |
| Accepted author manuscript | License File Access Level Controlled |
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