Melissa Min-Szu Yao1, Bonnie N Joe2, Edward A Sickles2, Cindy S Lee3. 1. Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei 116, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, 250 Wu-Hsing Street, Taipei 110, Taiwan. 2. Department of Radiology and Biomedical Imaging, University of California, San Francisco, 505 Parnassus Ave, San Francisco, CA 94143-0628. 3. Department of Radiology, New York University Langone Health, 765 Stewart Avenue, Garden City, NY 11530. Electronic address: Cindy.Lee3@nyumc.org.
Abstract
RATIONALE AND OBJECTIVES: The Breast Imaging-Reporting and Data System (BI-RADS) atlas defines category 5 assessments as appropriate only for lesions that are almost certainly cancer, with a positive predictive value (PPV) of ≥95%. This study aims to demonstrate the feasibility of classifying lesions at diagnostic breast imaging with sufficiently high PPV to merit category 5 assessments, and to identify those lesion descriptors that yield such a high PPV. MATERIALS AND METHODS: For this Health Insurance Portability and Accountability Act compliant and IRB exempt study, we reviewed diagnostic breast imaging examinations (mammography and/or ultrasound) assessed as highly suggestive of malignancy (BI-RADS category 5). Pathology diagnosis was considered the gold standard. PPV3 (biopsy performed) was calculated, and the BI-RADS descriptors for each lesion were analyzed. RESULTS: Among 22,564 consecutive diagnostic breast imaging examinations between January 2010 and September 2015, we identified 239 exams (1.1%) assessed as BI-RADS category 5 (mean age 62.5 years). Malignancy (invasive breast carcinoma and/or ductal carcinoma in situ) was diagnosed in 233 examinations (PPV3 97.5% and 95% confidence interval: 96.2%-98.8%). The most common lesion types were mass (170) and calcifications (116). Of the 220 examinations involving both mammography and ultrasound, no category 5 lesions had <3 suspicious BI-RADS descriptors, only three lesions had three suspicious descriptors, but the remaining 217 lesions (98.6%) had ≥4 suspicious descriptors. CONCLUSION: In clinical practice, it is feasible to make BI-RADS category 5 assessments with the intended ≥95% PPV. To justify a category 5 assessment, at least four suspicious BI-RADS descriptors should be identified at the combination of diagnostic mammography and ultrasound examinations.
RATIONALE AND OBJECTIVES: The Breast Imaging-Reporting and Data System (BI-RADS) atlas defines category 5 assessments as appropriate only for lesions that are almost certainly cancer, with a positive predictive value (PPV) of ≥95%. This study aims to demonstrate the feasibility of classifying lesions at diagnostic breast imaging with sufficiently high PPV to merit category 5 assessments, and to identify those lesion descriptors that yield such a high PPV. MATERIALS AND METHODS: For this Health Insurance Portability and Accountability Act compliant and IRB exempt study, we reviewed diagnostic breast imaging examinations (mammography and/or ultrasound) assessed as highly suggestive of malignancy (BI-RADS category 5). Pathology diagnosis was considered the gold standard. PPV3 (biopsy performed) was calculated, and the BI-RADS descriptors for each lesion were analyzed. RESULTS: Among 22,564 consecutive diagnostic breast imaging examinations between January 2010 and September 2015, we identified 239 exams (1.1%) assessed as BI-RADS category 5 (mean age 62.5 years). Malignancy (invasive breast carcinoma and/or ductal carcinoma in situ) was diagnosed in 233 examinations (PPV3 97.5% and 95% confidence interval: 96.2%-98.8%). The most common lesion types were mass (170) and calcifications (116). Of the 220 examinations involving both mammography and ultrasound, no category 5 lesions had <3 suspicious BI-RADS descriptors, only three lesions had three suspicious descriptors, but the remaining 217 lesions (98.6%) had ≥4 suspicious descriptors. CONCLUSION: In clinical practice, it is feasible to make BI-RADS category 5 assessments with the intended ≥95% PPV. To justify a category 5 assessment, at least four suspicious BI-RADS descriptors should be identified at the combination of diagnostic mammography and ultrasound examinations.