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

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. Sp...

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Autores principales: Sánchez-Bayuela, Daniel Álvarez, Ghavami, Navid, Tiberi, Gianluigi, Sani, Lorenzo, Vispa, Alessandro, Bigotti, Alessandra, Raspa, Giovanni, Badia, Mario, Papini, Lorenzo, Ghavami, Mohammad, Castellano, Cristina Romero, Bernardi, Daniela, Calabrese, Massimo, Tagliafico, Alberto Stefano
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10348515/
https://www.ncbi.nlm.nih.gov/pubmed/37450545
http://dx.doi.org/10.1371/journal.pone.0288312
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author Sánchez-Bayuela, Daniel Álvarez
Ghavami, Navid
Tiberi, Gianluigi
Sani, Lorenzo
Vispa, Alessandro
Bigotti, Alessandra
Raspa, Giovanni
Badia, Mario
Papini, Lorenzo
Ghavami, Mohammad
Castellano, Cristina Romero
Bernardi, Daniela
Calabrese, Massimo
Tagliafico, Alberto Stefano
author_facet Sánchez-Bayuela, Daniel Álvarez
Ghavami, Navid
Tiberi, Gianluigi
Sani, Lorenzo
Vispa, Alessandro
Bigotti, Alessandra
Raspa, Giovanni
Badia, Mario
Papini, Lorenzo
Ghavami, Mohammad
Castellano, Cristina Romero
Bernardi, Daniela
Calabrese, Massimo
Tagliafico, Alberto Stefano
author_sort Sánchez-Bayuela, Daniel Álvarez
collection PubMed
description 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.
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spelling pubmed-103485152023-07-15 A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection Sánchez-Bayuela, Daniel Álvarez Ghavami, Navid Tiberi, Gianluigi Sani, Lorenzo Vispa, Alessandro Bigotti, Alessandra Raspa, Giovanni Badia, Mario Papini, Lorenzo Ghavami, Mohammad Castellano, Cristina Romero Bernardi, Daniela Calabrese, Massimo Tagliafico, Alberto Stefano PLoS One Research Article 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. Public Library of Science 2023-07-14 /pmc/articles/PMC10348515/ /pubmed/37450545 http://dx.doi.org/10.1371/journal.pone.0288312 Text en © 2023 Sánchez-Bayuela et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Sánchez-Bayuela, Daniel Álvarez
Ghavami, Navid
Tiberi, Gianluigi
Sani, Lorenzo
Vispa, Alessandro
Bigotti, Alessandra
Raspa, Giovanni
Badia, Mario
Papini, Lorenzo
Ghavami, Mohammad
Castellano, Cristina Romero
Bernardi, Daniela
Calabrese, Massimo
Tagliafico, Alberto Stefano
A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title_full A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title_fullStr A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title_full_unstemmed A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title_short A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection
title_sort multicentric, single arm, prospective, stratified clinical investigation to evaluate mammowave’s ability in breast lesions detection
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10348515/
https://www.ncbi.nlm.nih.gov/pubmed/37450545
http://dx.doi.org/10.1371/journal.pone.0288312
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