Background : We sought to determine the diagnostic efficacy of Breast-specific gamma imaging (BSGI) in Chinese women with BI-RADS 4 category lesions and to compare this efficacy to that of ultrasound/mammography. Methods : We retrospectively assessed 177 women who had undergone BSGI of BI-RADS 4 category lesions detected via ultrasound and/or mammography. Results: Of the 177 cases, 117 (66.1%) were malignant lesions and 60 (33.9%) were benign. The sensitivity, specificity, positive, and negative predictive values of BSGI were 94.9% (111/117), 78.3% (47/60), 89.5% (111/124), and 88.7% (47/53), respectively. For mammography, the specificity and positive predictive values were 48.3% (29/60) and 77.5% (107/138), while for ultrasound they were 53.3% (32/60) and 79.6% (109/137). The sensitivity and specificity of BSGI for the detection lesions ≤1 cm were 90.9% (10/11) and 88.0% (22/25), while these values for breast lesions >1cm were 94.3% (100/106) and 71.4% (25/35), and these values for dense breast tissue were 94.0% (79/84) and 78.0% (39/50), as opposed to non-dense breast values of 97.0% (32/33) and 80.0% (8/10). The sensitivity of BSGI for invasive ductal carcinomas (IDC) and ductal carcinomas in situ (DCIS) were 98.9% (95/96) and 75.0% (9/12).The tumor to normal tissue ratio of BSGI for malignant lesions was significantly higher than that of benign lesions (2.18±1.17 vs 1.66±0.40, t =7.56, P <0.05). Conclusions : These results reveal that BSGI is highly sensitive, with good positive/negative predictive values. BSGI for IDC proved to be superior to DCIS for diagnosis of BI-RADS 4 category lesions as compared with ultrasound or mammography. BSGI showed perfect results in dense breasts and lesions ≤ 1 cm in size.