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MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial

In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strate...

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Autores principales: Bonelli, Luigina Ada, Calabrese, Massimo, Belli, Paolo, Corcione, Stefano, Losio, Claudio, Montemezzi, Stefania, Pediconi, Federica, Petrillo, Antonella, Zuiani, Chiara, Camera, Lucia, Carbonaro, Luca Alessandro, Cozzi, Andrea, De Falco Alfano, Daniele, Gristina, Licia, Panzeri, Marta, Poirè, Ilaria, Schiaffino, Simone, Tosto, Simona, Trecate, Giovanna, Trimboli, Rubina Manuela, Valdora, Francesca, Viganò, Sara, Sardanelli, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8469187/
https://www.ncbi.nlm.nih.gov/pubmed/34573983
http://dx.doi.org/10.3390/diagnostics11091635
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author Bonelli, Luigina Ada
Calabrese, Massimo
Belli, Paolo
Corcione, Stefano
Losio, Claudio
Montemezzi, Stefania
Pediconi, Federica
Petrillo, Antonella
Zuiani, Chiara
Camera, Lucia
Carbonaro, Luca Alessandro
Cozzi, Andrea
De Falco Alfano, Daniele
Gristina, Licia
Panzeri, Marta
Poirè, Ilaria
Schiaffino, Simone
Tosto, Simona
Trecate, Giovanna
Trimboli, Rubina Manuela
Valdora, Francesca
Viganò, Sara
Sardanelli, Francesco
author_facet Bonelli, Luigina Ada
Calabrese, Massimo
Belli, Paolo
Corcione, Stefano
Losio, Claudio
Montemezzi, Stefania
Pediconi, Federica
Petrillo, Antonella
Zuiani, Chiara
Camera, Lucia
Carbonaro, Luca Alessandro
Cozzi, Andrea
De Falco Alfano, Daniele
Gristina, Licia
Panzeri, Marta
Poirè, Ilaria
Schiaffino, Simone
Tosto, Simona
Trecate, Giovanna
Trimboli, Rubina Manuela
Valdora, Francesca
Viganò, Sara
Sardanelli, Francesco
author_sort Bonelli, Luigina Ada
collection PubMed
description In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strategy. Here, we describe the study protocol and the characteristics of enrolled patients for MRIB feasibility, multicenter, randomized, controlled trial, which aims to compare MRI alone versus MX+US in women at intermediate breast cancer risk (aged 40–59, with a 15–30% BC-LTR and/or extremely dense breasts). Two screening rounds per woman were planned in ten centers experienced in MRI screening, the primary endpoint being the rate of cancers detected in the 2 arms after 5 years of follow-up. From July 2013 to November 2015, 1254 women (mean age 47 years) were enrolled: 624 were assigned to MX+US and 630 to MRI. Most of them were aged below 50 (72%) and premenopausal (45%), and 52% used oral contraceptives. Among postmenopausal women, 15% had used hormone replacement therapy. Breast and/or ovarian cancer in mothers and/or sisters were reported by 37% of enrolled women, 79% had extremely dense breasts, and 41% had a 15–30% BC-LTR. The distribution of the major determinants of breast cancer risk profiles (breast density and family history of breast and ovarian cancer) of enrolled women varied across centers.
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spelling pubmed-84691872021-09-27 MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial Bonelli, Luigina Ada Calabrese, Massimo Belli, Paolo Corcione, Stefano Losio, Claudio Montemezzi, Stefania Pediconi, Federica Petrillo, Antonella Zuiani, Chiara Camera, Lucia Carbonaro, Luca Alessandro Cozzi, Andrea De Falco Alfano, Daniele Gristina, Licia Panzeri, Marta Poirè, Ilaria Schiaffino, Simone Tosto, Simona Trecate, Giovanna Trimboli, Rubina Manuela Valdora, Francesca Viganò, Sara Sardanelli, Francesco Diagnostics (Basel) Study Protocol In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strategy. Here, we describe the study protocol and the characteristics of enrolled patients for MRIB feasibility, multicenter, randomized, controlled trial, which aims to compare MRI alone versus MX+US in women at intermediate breast cancer risk (aged 40–59, with a 15–30% BC-LTR and/or extremely dense breasts). Two screening rounds per woman were planned in ten centers experienced in MRI screening, the primary endpoint being the rate of cancers detected in the 2 arms after 5 years of follow-up. From July 2013 to November 2015, 1254 women (mean age 47 years) were enrolled: 624 were assigned to MX+US and 630 to MRI. Most of them were aged below 50 (72%) and premenopausal (45%), and 52% used oral contraceptives. Among postmenopausal women, 15% had used hormone replacement therapy. Breast and/or ovarian cancer in mothers and/or sisters were reported by 37% of enrolled women, 79% had extremely dense breasts, and 41% had a 15–30% BC-LTR. The distribution of the major determinants of breast cancer risk profiles (breast density and family history of breast and ovarian cancer) of enrolled women varied across centers. MDPI 2021-09-08 /pmc/articles/PMC8469187/ /pubmed/34573983 http://dx.doi.org/10.3390/diagnostics11091635 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Bonelli, Luigina Ada
Calabrese, Massimo
Belli, Paolo
Corcione, Stefano
Losio, Claudio
Montemezzi, Stefania
Pediconi, Federica
Petrillo, Antonella
Zuiani, Chiara
Camera, Lucia
Carbonaro, Luca Alessandro
Cozzi, Andrea
De Falco Alfano, Daniele
Gristina, Licia
Panzeri, Marta
Poirè, Ilaria
Schiaffino, Simone
Tosto, Simona
Trecate, Giovanna
Trimboli, Rubina Manuela
Valdora, Francesca
Viganò, Sara
Sardanelli, Francesco
MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title_full MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title_fullStr MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title_full_unstemmed MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title_short MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
title_sort mri versus mammography plus ultrasound in women at intermediate breast cancer risk: study design and protocol of the mrib multicenter, randomized, controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8469187/
https://www.ncbi.nlm.nih.gov/pubmed/34573983
http://dx.doi.org/10.3390/diagnostics11091635
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