MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial
Luigina Ada Bonelli,
Massimo Calabrese,
Paolo Belli,
Stefano Corcione,
Claudio Losio,
Stefania Montemezzi,
Federica Pediconi,
Antonella Petrillo,
Chiara Zuiani,
Lucia Camera,
Luca Alessandro Carbonaro,
Andrea Cozzi,
Daniele De Falco Alfano,
Licia Gristina,
Marta Panzeri,
Ilaria Poirè,
Simone Schiaffino,
Simona Tosto,
Giovanna Trecate,
Rubina Manuela Trimboli,
Francesca Valdora,
Sara Viganò,
Francesco Sardanelli
Affiliations
Luigina Ada Bonelli
Unit of Clinical Epidemiology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Massimo Calabrese
Unit of Diagnostic Senology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Paolo Belli
Department of Radiological, Radiotherapic and Hematological Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Roma, Italy
Stefano Corcione
Breast Imaging Unit, Arcispedale Sant’Anna, Azienda Ospedaliero-Universitaria di Ferrara, 44124 Cona, Italy
Claudio Losio
Unit of Senology, IRCCS Ospedale San Raffaele, 20132 Milano, Italy
Stefania Montemezzi
Unit of Radiology BT, Azienda Ospedaliera Universitaria Integrata, 37126 Verona, Italy
Federica Pediconi
Department of Radiological, Oncological and Pathological Sciences, Università degli Studi “La Sapienza”, 00161 Roma, Italy
Antonella Petrillo
Radiology Unit, Istituto Nazionale dei Tumori IRCCS Fondazione G. Pascale, 80131 Napoli, Italy
Chiara Zuiani
Institute of Radiology, Azienda Ospedaliera Universitaria “Santa Maria della Misericordia”, Università degli Studi di Udine, 33100 Udine, Italy
Lucia Camera
Unit of Radiology BT, Azienda Ospedaliera Universitaria Integrata, 37126 Verona, Italy
Luca Alessandro Carbonaro
Unit of Radiology, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy
Andrea Cozzi
Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milano, Italy
Daniele De Falco Alfano
Breast Imaging Unit, Arcispedale Sant’Anna, Azienda Ospedaliero-Universitaria di Ferrara, 44124 Cona, Italy
Licia Gristina
Unit of Diagnostic Senology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Marta Panzeri
Unit of Senology, IRCCS Ospedale San Raffaele, 20132 Milano, Italy
Ilaria Poirè
Unit of Clinical Epidemiology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Simone Schiaffino
Unit of Radiology, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy
Simona Tosto
Unit of Diagnostic Senology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Giovanna Trecate
Department of Diagnostic Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
Rubina Manuela Trimboli
Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milano, Italy
Francesca Valdora
Unit of Diagnostic Senology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
Sara Viganò
Department of Diagnostic Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
Francesco Sardanelli
Unit of Radiology, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy
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.