Department of Interventional Ultrasound, Fifth Medical Center of Chinese PLA General Hospital & Chinese PLA Medical School, Beijing, 100039, China.
Department of Interventional Ultrasound, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Breast Cancer Res. 2023 May 30;25(1):61. doi: 10.1186/s13058-023-01650-3.
Multiparametric magnetic resonance imaging (MP-MRI) has high sensitivity for diagnosing breast cancers but cannot always be used as a routine diagnostic tool. The present study aimed to evaluate whether the diagnostic performance of perfluorobutane (PFB) contrast-enhanced ultrasound (CEUS) is similar to that of MP-MRI in breast cancer and whether combining the two methods would enhance diagnostic efficiency.
This was a head-to-head, prospective, multicenter study. Patients with breast lesions diagnosed by US as Breast Imaging Reporting and Data System (BI-RADS) categories 3, 4, and 5 underwent both PFB-CEUS and MP-MRI scans. On-site operators and three reviewers categorized the BI-RADS of all lesions on two images. Logistic-bootstrap 1000-sample analysis and cross-validation were used to construct PFB-CEUS, MP-MRI, and hybrid (PFB-CEUS + MP-MRI) models to distinguish breast lesions.
In total, 179 women with 186 breast lesions were evaluated from 17 centers in China. The area under the receiver operating characteristic curve (AUC) for the PFB-CEUS model to diagnose breast cancer (0.89; 95% confidence interval [CI] 0.74, 0.97) was similar to that of the MP-MRI model (0.89; 95% CI 0.73, 0.97) (P = 0.85). The AUC of the hybrid model (0.92, 95% CI 0.77, 0.98) did not show a statistical advantage over the PFB-CEUS and MP-MRI models (P = 0.29 and 0.40, respectively). However, 90.3% false-positive and 66.7% false-negative results of PFB-CEUS radiologists and 90.5% false-positive and 42.8% false-negative results of MP-MRI radiologists could be corrected by the hybrid model. Three dynamic nomograms of PFB-CEUS, MP-MRI and hybrid models to diagnose breast cancer are freely available online.
PFB-CEUS can be used in the differential diagnosis of breast cancer with comparable performance to MP-MRI and with less time consumption. Using PFB-CEUS and MP-MRI as joint diagnostics could further strengthen the diagnostic ability. Trial registration Clinicaltrials.gov; NCT04657328. Registered 26 September 2020. IRB number 2020-300 was approved in Chinese PLA General Hospital. Every patient signed a written informed consent form in each center.
多参数磁共振成像(MP-MRI)在诊断乳腺癌方面具有很高的敏感性,但不能始终作为常规诊断工具。本研究旨在评估全氟丁烷(PFB)超声造影(CEUS)的诊断性能是否与 MP-MRI 在乳腺癌中的诊断性能相当,以及两种方法联合使用是否会提高诊断效率。
这是一项头对头、前瞻性、多中心研究。经超声诊断为乳腺影像报告和数据系统(BI-RADS)类别 3、4 和 5 的患者进行 PFB-CEUS 和 MP-MRI 扫描。现场操作人员和三位审阅者对两种图像上的所有病变进行 BI-RADS 分类。使用逻辑-bootstrap 1000 个样本分析和交叉验证构建 PFB-CEUS、MP-MRI 和混合(PFB-CEUS+MP-MRI)模型,以区分乳腺病变。
本研究共纳入来自中国 17 个中心的 179 名女性的 186 个乳腺病变。PFB-CEUS 模型诊断乳腺癌的受试者工作特征曲线下面积(AUC)为 0.89(95%置信区间 [CI] 0.74,0.97),与 MP-MRI 模型(0.89;95%CI 0.73,0.97)相似(P=0.85)。混合模型(0.92,95%CI 0.77,0.98)的 AUC 与 PFB-CEUS 和 MP-MRI 模型均无统计学差异(P=0.29 和 0.40)。然而,PFB-CEUS 放射科医生 90.3%的假阳性和 66.7%的假阴性结果以及 MP-MRI 放射科医生 90.5%的假阳性和 42.8%的假阴性结果可以通过混合模型纠正。三种用于诊断乳腺癌的 PFB-CEUS、MP-MRI 和混合模型的动态 nomogram 可在网上免费获得。
PFB-CEUS 可用于乳腺癌的鉴别诊断,与 MP-MRI 相比具有相当的性能,且耗时更少。联合使用 PFB-CEUS 和 MP-MRI 进行诊断可进一步增强诊断能力。
Clinicaltrials.gov;NCT04657328。于 2020 年 9 月 26 日注册。中国人民解放军总医院的 IRB 编号为 2020-300。每位患者在每个中心都签署了书面知情同意书。