PurposeThe objective of this study was to investigate the independent risk factors and associated predictive values of contrast-enhanced ultrasound (CEUS), shear wave elastography (SWE), and strain elastography (SE) for high-risk lesions (HRL) and malignant tumors (MT) among nonpalpable breast masses classified as BI-RADS category 4 on conventional ultrasound. MethodsThis prospective study involved consecutively admitted patients with breast tumors from January 2018, aiming to explore the management of BI-RADS category 4 breast tumors using CEUS and elastography. We conducted a retrospective review of patient data, focusing on those with a history of a nonpalpable mass as the primary complaint. Pathologic findings after surgical resection served as the gold standard. The CEUS arterial-phase indices were analyzed using contrast agent arrival-time parametric imaging processing mode, while quantitative and qualitative indices were examined on ES images. Independent risk factors were identified through binary logistic regression multifactorial analysis. The predictive efficacy of different modalities was compared using a receiver operating characteristics curve. Subsequently, a nomogram for predicting the risk of HRL/MT was established based on a multifactorial logistic regression model. ResultsA total of 146 breast masses from 146 patients were included, comprising 80 benign tumors, 12 HRLs, and 54 MTs based on the final pathology. There was no significant difference in pathologic size between the benign and HRL/MT groups [8.00(6.25,10.00) vs. 9.00(6.00,10.00), P = 0.506]. The diagnostic efficacy of US plus CEUS exceeded that of US plus SWE/SE for BI-RADS 4 nonpalpable masses, with an AUC of 0.954 compared to 0.798/0.741 (P < 0.001). Further stratified analysis revealed a more pronounced improvement for reclassification of BI-RADS 4a masses (AUC: 0.943 vs. 0.762/0.675, P < 0.001) than BI-RADS 4b (AUC:0.950 vs. 0.885/0.796, P>0.05) with the assistance of CEUS than SWE/SE. Employing downgrade CEUS strategies resulted in negative predictive values ranging from 95.2 % to 100.0 % for BI-RADS 4a and 4b masses. Conversely, using upgrade nomogram strategies, which included the independent predictive risk factors of irregular enhanced shape, poor defined enhanced margin, earlier enhanced time, increased surrounding vessels, and presence of contrast agent retention, the diagnostic performance achieved an AUC of 0.947 with good calibration. ConclusionAfter investigating the potential of CEUS and ES in improving risk assessment and diagnostic accuracy for nonpalpable BI-RADS category 4 breast masses, it is evident that CEUS has a more significant impact on enhancing classification compared to ES, particularly for BI-RADS 4a subgroup masses. This finding suggests that CEUS may offer greater benefits in improving risk assessment and diagnostic accuracy for this specific subgroup of breast masses.