Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1784573866285203456 |
---|---|
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. |
format | Online Article Text |
id | pubmed-8469187 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT bonelliluiginaada mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT calabresemassimo mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT bellipaolo mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT corcionestefano mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT losioclaudio mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT montemezzistefania mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT pediconifederica mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT petrilloantonella mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT zuianichiara mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT cameralucia mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT carbonarolucaalessandro mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT cozziandrea mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT defalcoalfanodaniele mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT gristinalicia mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT panzerimarta mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT poireilaria mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT schiaffinosimone mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT tostosimona mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT trecategiovanna mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT trimbolirubinamanuela mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT valdorafrancesca mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT viganosara mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial AT sardanellifrancesco mriversusmammographyplusultrasoundinwomenatintermediatebreastcancerriskstudydesignandprotocolofthemribmulticenterrandomizedcontrolledtrial |