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

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.

Does MRI have added value in ultrasound-detected BIRADS-3 breast masses in candidates for assisted reproductive therapy?

“…In this regard, MRI could detect the lesions in the high-risk population with higher sensitivity and in earlier stages [24] . In the case of challenging populations and lesions like the BIRADS-3, the results of different modalities vary among individuals and trials are going on to find out the best approach [25] .…”

Advanced Magnetic Resonance Imaging Modalities for Breast Cancer Diagnosis: An Overview of Recent Findings and Perspectives

“…Generally, breast cancer can be examined with various techniques such as ultrasound, mammography, perfusion, and diffusion. According to many cohort and systematic studies, the sensitivity of MRI is higher than mammography, ultrasound, and a combination of ultrasound and mammography [ 42 , 43 , 44 , 45 , 46 ].…”

A Score to Predict the Malignancy of a Breast Lesion Based on Different Contrast Enhancement Patterns in Contrast-Enhanced Spectral Mammography

“…Furthermore, the difficulty of US (compared to mammography) to depict microcalcifications reduces the sensitivity in those forms of breast malignancies that present only as microcalcifications [ 16 , 17 , 18 ]. Finally, MRI is characterized by a higher sensitivity than FFDM and US for its ability to detect tumor angiogenesis through contrast enhancement [ 19 , 20 , 21 , 22 ]. However, the specificity of MRI is worsened by a high false-positive rate [ 23 , 24 , 25 ].…”