Multi-parameter ultrasonography-based predictive model for breast cancer diagnosis.

Objectives: To develop, validate, and evaluate a predictive model for breast cancer diagnosis using conventional ultrasonography (US), shear wave elastography (SWE), and contrast-enhanced US (CEUS). Materials and methods: This retrospective study included 674 patients with 674 breast lesions. The data, a main and an independent datasets, were divided into three cohorts. Cohort 1 (80% of the main dataset; n = 448) was analyzed by logistic regression analysis to identify risk factors and establish the predictive model. The area under the receiver operating characteristic curve (AUC) was analyzed in Cohort 2 (20% of the main dataset; n = 119) to validate and in Cohort 3 (the independent dataset; n = 107) to evaluate the predictive model. Results: Multivariable regression analysis revealed nine independent breast cancer risk factors, including age > 40 years; ill-defined margin, heterogeneity, rich blood flow, and abnormal axillary lymph nodes on US; enhanced area enlargement, contrast agent retention, and irregular shape on CEUS; mean SWE higher than the cutoff value (P < 0.05 for all). The diagnostic performance of the model was good, with AUC values of 0.847, 0.857, and 0.774 for Cohorts 1, 2, and 3, respectively. The model increased the diagnostic specificity (from 31% to 81.3% and 7.3% to 73.1% in cohorts 2 and 3, respectively) without a significant loss in sensitivity (from 100.0% to 90.1% and 100.0% to 81.8% in cohorts 2 and 3, respectively). Conclusion: The multi-parameter US-based model showed good performance in breast cancer diagnosis, improving specificity without a significant loss in sensitivity. Using the model could reduce unnecessary biopsies and guide clinical diagnosis and treatment.