Abstract
INTRODUCTION: The Breast Imaging-Reporting and Database System (BI-RADS) category 4 is designated for breast lumps that do not display the typical features of malignancy but still raise enough suspicion to warrant a recommendation for a biopsy, as malignancy cannot be ruled out through imaging alone. The main objective of this study was to investigate the sonographic characteristics and pathology correlation of BI-RADS 4 breast lesions and determine the positive predictive rate of BI-RADS 4 lesions in diagnosing breast cancer, using histopathology as the gold standard. METHODS: This was a cross-sectional study conducted at the Department of Radiology, Aga Khan University Hospital in Karachi, spanning from May 2021 to August 2022, with a duration of 15 months. The study focused on female patients over the age of 18 who presented with suspicious breast lesions on ultrasound. Both mammography and ultrasound-guided core needle biopsy were performed on these patients, followed by a detailed histopathological evaluation of the biopsy specimens. To calculate the positive predictive value (PPV), true positive cases were identified through both histopathology and ultrasonography. RESULTS: A total of 227 cases were categorized as BI-RADS 4 lesions, with the patients' mean age being 47.8 ± 14.3 years (range: 17 - 88). Among the biopsied lesions, 101 cases were confirmed to be true positive for breast malignancies, resulting in a PPV for malignancy of 44.9%. Conversely, there were 124 false positive cases out of the 227 BI-RADS 4 category lesions (54.63%). The primary indication for presentation was a breast lump, and out of the 101 confirmed malignant cases, 70 (69.3%) were associated with malignancy. CONCLUSION: BI-RADS 4 can be utilized to assess suspicious breast lumps; however, for more reliable results and to avoid false negatives, histopathological confirmation should complement the imaging findings.