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Volume 11
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10.3390/diagnostics11091635
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Study Protocol

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

by
Luigina Ada Bonelli
1,*,
Massimo Calabrese
2,
Paolo Belli
3,
Stefano Corcione
4,†,
Claudio Losio
5,
Stefania Montemezzi
6,
Federica Pediconi
7,
Antonella Petrillo
8,
Chiara Zuiani
9,
Lucia Camera
6,
Luca Alessandro Carbonaro
10,11,12,
Andrea Cozzi
13,
Daniele De Falco Alfano
4,14,
Licia Gristina
2,
Marta Panzeri
5,
Ilaria Poirè
1,
Simone Schiaffino
10,
Simona Tosto
2,
Giovanna Trecate
15,
Rubina Manuela Trimboli
13,16,
Francesca Valdora
2,
Sara Viganò
15 and
Francesco Sardanelli
10,13add Show full author list remove Hide full author list
1
Unit of Clinical Epidemiology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
2
Unit of Diagnostic Senology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
3
Department of Radiological, Radiotherapic and Hematological Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Roma, Italy
4
Breast Imaging Unit, Arcispedale Sant’Anna, Azienda Ospedaliero-Universitaria di Ferrara, 44124 Cona, Italy
5
Unit of Senology, IRCCS Ospedale San Raffaele, 20132 Milano, Italy
6
Unit of Radiology BT, Azienda Ospedaliera Universitaria Integrata, 37126 Verona, Italy
7
Department of Radiological, Oncological and Pathological Sciences, Università degli Studi “La Sapienza”, 00161 Roma, Italy
8
Radiology Unit, Istituto Nazionale dei Tumori IRCCS Fondazione G. Pascale, 80131 Napoli, Italy
9
Institute of Radiology, Azienda Ospedaliera Universitaria “Santa Maria della Misericordia”, Università degli Studi di Udine, 33100 Udine, Italy
10
Unit of Radiology, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy
11
Department of Radiology, Grande Ospedale Metropolitano Niguarda, 20162 Milano, Italy
12
Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, 20122 Milano, Italy
13
Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milano, Italy
14
Mammography Center, Radiology Unit, Policlinico Sant’Orsola–Malpighi, 40138 Bologna, Italy
15
Department of Diagnostic Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
16
Breast Imaging and Screening Unit, Department of Radiology, Humanitas Clinical and Research Center—IRCCS, 20089 Rozzano, Italy
 
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*
Author to whom correspondence should be addressed.
†
Dr. Stefano Corcione passed away on 18 February 2018.
Diagnostics 2021, 11(9), 1635; https://doi.org/10.3390/diagnostics11091635
Submission received: 8 August 2021 / Revised: 27 August 2021 / Accepted: 31 August 2021 / Published: 8 September 2021
(This article belongs to the Section Medical Imaging and Theranostics)
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Abstract

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.
Keywords: intermediate breast cancer risk; screening; contrast-enhanced magnetic resonance imaging; mammography; ultrasound intermediate breast cancer risk; screening; contrast-enhanced magnetic resonance imaging; mammography; ultrasound

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MDPI and ACS Style

Bonelli, L.A.; Calabrese, M.; Belli, P.; Corcione, S.; Losio, C.; Montemezzi, S.; Pediconi, F.; Petrillo, A.; Zuiani, C.; Camera, L.; et al. MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial. Diagnostics 2021, 11, 1635. https://doi.org/10.3390/diagnostics11091635

AMA Style

Bonelli LA, Calabrese M, Belli P, Corcione S, Losio C, Montemezzi S, Pediconi F, Petrillo A, Zuiani C, Camera L, et al. MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial. Diagnostics. 2021; 11(9):1635. https://doi.org/10.3390/diagnostics11091635

Chicago/Turabian Style

Bonelli, Luigina Ada, Massimo Calabrese, Paolo Belli, Stefano Corcione, Claudio Losio, Stefania Montemezzi, Federica Pediconi, Antonella Petrillo, Chiara Zuiani, Lucia Camera, and et al. 2021. "MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial" Diagnostics 11, no. 9: 1635. https://doi.org/10.3390/diagnostics11091635

APA Style

Bonelli, L. A., Calabrese, M., Belli, P., Corcione, S., Losio, C., Montemezzi, S., Pediconi, F., Petrillo, A., Zuiani, C., Camera, L., Carbonaro, L. A., Cozzi, A., De Falco Alfano, D., Gristina, L., Panzeri, M., Poirè, I., Schiaffino, S., Tosto, S., Trecate, G., ... Sardanelli, F. (2021). MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial. Diagnostics, 11(9), 1635. https://doi.org/10.3390/diagnostics11091635

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