Characteristics, Malignancy Rate, and Follow-up of BI-RADS Category 3 Lesions Identified at Breast MR Imaging: Implications for MR Image Interpretation and Management.

Purpose To (a) evaluate the frequency of Breast Imaging Reporting and Data System (BI-RADS) category 3 assessment in screening and diagnostic breast magnetic resonance (MR) imaging, (b) review findings considered indicative of BI-RADS category 3, and (c) determine outcomes of BI-RADS category 3 lesions, including upgrades, downgrades, and malignancy rates. Materials and Methods This retrospective study was approved by the institutional review board and compliant with HIPAA. The authors retrospectively reviewed the breast MR imaging database (2009-2011) to identify breast MR images classified as showing BI-RADS category 3 lesions. There were 9216 BI-RADS assessments in 5778 examinations (3360 women). Of the 9216 assessments, 567 (6%) in 483 women (average age, 47.2 years; median age, 47.0 years) were assigned BI-RADS category 3. In women with more than one BI-RADS category 3 lesion, the first lesion reported in the impression was used for data analysis. Outcomes data were available for 435 of the 483 women (90.1%). These women comprised the study cohort. Medical records from January 1, 2009, to May 31, 2015, were reviewed to obtain demographic characteristics and outcomes. χ(2) statistics and 95% exact confidence intervals (CIs) were constructed. Results MR imaging was performed for high-risk screening in 240 of the 435 patients (55.2%) and for diagnostic purposes in 195 (44.8%). Findings included mass (n = 125, 28.7%), focus (n = 111, 25.5%), nonmass enhancement (n = 80, 18.3%), moderate or marked background parenchymal enhancement (BPE) (n = 91, 20.9%), posttreatment changes (n = 16, 3.8%), and other findings (n = 12, 2.8%). Outcomes were as follows: 339 of the 435 patients (78%) did not have evidence of malignancy at more than 24 months, 28 (6.4%) underwent mastectomy (all benign), and 68 (15.6%) had lesion upgrades, with 11 cancers (2.5%). All 11 cancers were diagnosed in women with a genetic mutation or a personal history of breast cancer. No cancer was detected in cases of moderate or marked BPE. Conclusion Six percent of all breast MR imaging assessments were categorized as BI-RADS category 3, with a cancer rate of 2.5% (95% CI: 1.3%, 4.5%). All cancers were in women with a genetic mutation or personal history of breast cancer. Marked BPE does not necessitate a BI-RADS 3 assessment. (©) RSNA, 2016.