Head-to-head Comparison of Perfluorobutane-Contrast Enhanced US and Multiparametric-MRI for Breast Cancer: A prospective, multicenter study

Abstract

Abstract Background: Multiparametric - Magnetic Resonance Imaging (MP-MRI) has high sensitivity for diagnosing breast cancers but cannot always be used as a routine diagnostic tool. To evaluate whether the diagnostic performance of Perfluorobutane (PFB)-contrast enhanced ultrasound (CEUS) is like MP-MRI in the breast cancer and if combining the two methods would enhance diagnostic efficiency. Patients and Methods: 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) 3, 4, and 5 categories underwent both PFB-CEUS and MP-MRI scans. On-site operators and three reviewers categorized the BI-RADS of all lesions on two images, respectively. 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. Results: 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 (0.89; 95% confidence interval [CI]: 0.74, 0.97) was like that of the MP-MRI model (0.89; 95% CI: 0.73, 0.97), whereas both were inferior to the hybrid model (0.92, 95% CI: 0.77, 0.98). 90.3% false-positive and 66.7% false-negative results of PFB-CEUS radiologists, 90.5% false-positive and 42.8% false-negative results of MP-MRI radiologists could be corrected by Hybrid model, respectively. Dynamic nomograms of three models are accessible on websites. Conclusions: PFB-CEUS can be used in differential diagnosis of breast cancer with the performance comparable to MP-MRI. Using PFB-CEUS and MP-MRI as joint diagnostics could further strengthen the diagnostic ability. Trial registration: Clinicaltrials.gov; NCT04657328. Registered 26 September 2020.