Xing Boyuan, Gu Chen, Fu Chenghui, Zhang Bingyi, Tan Yandi
Department of Ultrasound, The First College of Clinical Medical Science, Yichang Central People's Hospital, China Three Gorges University, Yichang, China.
Third-grade Pharmacological Laboratory on Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine, China Three Gorges University, Yichang, China.
BMC Cancer. 2025 Aug 12;25(1):1306. doi: 10.1186/s12885-025-14760-2.
This study aimed to explore the diagnostic performance of ultrasound S-Detect in differentiating Breast Imaging-Reporting and Data System (BI-RADS) 4 breast nodules ≤ 20 mm and > 20 mm.
Between November 2020 and November 2022, a total of 382 breast nodules in 312 patients were classified as BI-RADS-4 by conventional ultrasound. Using pathology results as the gold standard, we applied receiver operator characteristics (ROC), sensitivity (SE), specificity (SP), accuracy (ACC), positive predictive value (PPV), and negative predictive value (NPV) to analyze the diagnostic value of BI-RADS, S-Detect, and the two techniques in combination (Co-Detect) in the diagnosis of BI-RADS 4 breast nodules ≤ 20 mm and > 20 mm.
There were 382 BI-RADS-4 nodules, of which 151 were pathologically confirmed as malignant, and 231 as benign. In lesions ≤ 20 mm, the SE, SP, ACC, PPV, NPV, and area under the curve (AUC) of the BI-RADS group were 77.27%, 89.73%, 85.71%, 78.16%, 89.24%, 0.835, respectively. SE, SP, ACC, PPV, NPV, and AUC of the S-Detect group were 92.05%, 78.92%, 83.15%, 67.50%, 95.43%, 0.855, respectively. SE, SP, ACC, PPV, NPV, and AUC of the Co-Detect group were 89.77%, 93.51%, 92.31%, 86.81%, 95.05%, 0.916, respectively. The differences of SE, ACC, NPV, and AUC between the BI-RADS group and the Co-Detect group were statistically significant (P < 0.05). In lesions > 20 mm, SE, SP, ACC, PPV, NPV, and AUC of the BI-RADS group were 88.99%, 89.13%, 88.99%, 91.80%, 85.42%, 0.890, respectively. SE, SP, ACC, PPV, NPV, and AUC of the S-Detect group were 98.41%, 69.57%, 86.24%, 81.58%, 96.97%, 0.840, respectively. SE, SP, ACC, PPV, NPV, and AUC of the Co-Detect group were 98.41%, 91.30%, 95.41%, 93.94%, 97.67%, 0.949, respectively. A total of 166 BI-RADS 4 A nodules were downgraded to category 3 by Co-Detect, with 160 (96.4%) confirmed as benign and 6 (all ≤ 20 mm) as false negatives. Conversely, 25 nodules were upgraded to 4B, of which 19 (76.0%) were malignant. The difference in AUC between the BI-RADS group and the Co-Detect group was statistically significant (P < 0.05).
S-Detect combined with BI-RADS is effective in the differential diagnosis of BI-RADS 4 breast nodules ≤ 20 mm and > 20 mm. However, its performance is particularly pronounced in lesions ≤ 20 mm, where it contributes to a significant reduction in unnecessary biopsies.
本研究旨在探讨超声S-Detect在鉴别乳腺影像报告和数据系统（BI-RADS）4类、直径≤20 mm和>20 mm的乳腺结节中的诊断性能。
2020年11月至2022年11月期间，312例患者的382个乳腺结节经传统超声分类为BI-RADS-4类。以病理结果为金标准，应用受试者操作特征（ROC）、灵敏度（SE）、特异度（SP）、准确度（ACC）、阳性预测值（PPV）和阴性预测值（NPV）分析BI-RADS、S-Detect以及两者联合（联合检测）在诊断直径≤20 mm和>20 mm的BI-RADS 4类乳腺结节中的诊断价值。
共有382个BI-RADS-4类结节，其中151个经病理证实为恶性，231个为良性。在直径≤20 mm的病变中，BI-RADS组的SE、SP、ACC、PPV、NPV和曲线下面积（AUC）分别为77.27%、89.73%、85.71%、78.16%、89.24%、0.835。S-Detect组的SE、SP、ACC、PPV、NPV和AUC分别为92.05%、78.92%、83.15%、67.50%、95.43%、0.855。联合检测组的SE、SP、ACC、PPV、NPV和AUC分别为89.77%、93.51%、92.31%、86.81%、95.05%、0.916。BI-RADS组与联合检测组在SE、ACC、NPV和AUC方面的差异具有统计学意义（P<0.05）。在直径>20 mm的病变中，BI-RADS组的SE、SP、ACC、PPV、NPV和AUC分别为88.99%、89.13%、88.99%、91.80%、85.42%、0.890。S-Detect组的SE、SP、ACC、PPV、NPV和AUC分别为98.41%、69.57%、86.24%、81.58%、96.97%、0.840。联合检测组的SE、SP、ACC、PPV、NPV和AUC分别为98.41%、91.30%、95.41%、93.94%、97.67%、0.949。共有166个BI-RADS 4A类结节经联合检测降级为3类，其中160个（96.4%）被证实为良性，6个（均≤20 mm）为假阴性。相反，25个结节升级为4B类，其中19个（76.0%）为恶性。BI-RADS组与联合检测组在AUC方面的差异具有统计学意义（P<0.05）。
S-Detect联合BI-RADS对直径≤20 mm和>20 mm的BI-RADS 4类乳腺结节的鉴别诊断有效。然而，其性能在直径≤20 mm的病变中尤为显著，有助于显著减少不必要的活检。
