Diagnostics (Sep 2021)

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

DOI
https://doi.org/10.3390/diagnostics11091635
Journal volume & issue
Vol. 11, no. 9
p. 1635

Abstract

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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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