Ultrasound Department, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.
Department of Ultrasound, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, China.
Ultrasound Med Biol. 2024 Aug;50(8):1224-1231. doi: 10.1016/j.ultrasmedbio.2024.04.010. Epub 2024 May 24.
The main aim of this study was to determine whether the use of contrast-enhanced ultrasound (CEUS) could improve the categorization of suspicious breast lesions based on the Breast Imaging Reporting and Data System (BI-RADS), thereby reducing the number of benign breast lesions referred for biopsy.
This prospective study, conducted between January 2017 and December 2018, enrolled consenting patients from eight teaching hospitals in China, who had been diagnosed with solid breast lesions classified as BI-RADS 4 using conventional ultrasound. CEUS was performed within 1 wk of diagnosis for reclassification of breast lesions. Histopathological results obtained from core needle biopsies or surgical excision samples served as the reference standard. The simulated biopsy rate and cancer-to-biopsy yield were used to compare the accuracy of CEUS and conventional ultrasound (US).
Among the 1490 lesions diagnosed as BI-RADS 4 with conventional ultrasound, 486 malignant and 1004 benign lesions were confirmed based on histology. Following CEUS, 2, 395, and 211 lesions were reclassified as CEUS-based BI-RADS 2, 3, and 5, respectively, while 882 (59%) remained as BI-RADS 4. The actual cancer-to-biopsy yield based on US was 32.6%, which increased to 43.4% when CEUS-based BI-RADS 4A was used as the cut-off point to recommend biopsy. The simulated biopsy rate decreased to 73.4%. Overall, in this preselected BI-RADS 4 population, only 2.5% (12/486) of malignant lesions would have been miscategorized as BI-RADS 3 using CEUS-based reclassification. The diagnostic accuracy, sensitivity, and specificity of contrast-enhanced ultrasound reclassification were 57.65%, 97.53%, and 38.35%, respectively.
Our collective findings indicate that CEUS is a valuable tool in further triage of BI-RADS category 4 lesions and facilitates a reduction in the number of biopsies while increasing the cancer-to-biopsy yield.
本研究的主要目的是确定对比增强超声（CEUS）是否能够改善基于乳腺影像报告和数据系统（BI-RADS）对可疑乳腺病变的分类，从而减少需要活检的良性乳腺病变数量。
这项前瞻性研究于 2017 年 1 月至 2018 年 12 月期间在中国 8 所教学医院进行，纳入了经常规超声诊断为 BI-RADS 4 类的实性乳腺病变的患者。在诊断后 1 周内进行 CEUS 检查，以重新分类乳腺病变。从核心针活检或手术切除样本中获得的组织病理学结果作为参考标准。使用模拟活检率和癌症活检率来比较 CEUS 和常规超声（US）的准确性。
在 1490 例经常规超声诊断为 BI-RADS 4 类的病变中，根据组织学检查结果，486 例为恶性病变，1004 例为良性病变。CEUS 后，2、395 和 211 例病变分别重新分类为 CEUS 基于 BI-RADS 2、3 和 5 类，而 882 例（59%）仍为 BI-RADS 4 类。基于 US 的实际癌症活检率为 32.6%，当使用 CEUS 基于 BI-RADS 4A 作为活检推荐的切点时，该比率增加至 43.4%。模拟活检率降至 73.4%。总体而言，在这个预先选择的 BI-RADS 4 人群中，只有 2.5%（12/486）的恶性病变会被 CEUS 重新分类错误地归类为 BI-RADS 3 类。CEUS 重新分类的诊断准确性、敏感性和特异性分别为 57.65%、97.53%和 38.35%。
我们的研究结果表明，CEUS 是进一步分类 BI-RADS 4 类病变的有价值的工具，有助于减少活检数量，同时提高癌症活检率。
