Objective: The primary aim of this study is to assess the diagnostic efficacy of elastography and contrast-enhanced ultrasound (CEUS) in the identification of breast lesions subsequent to the optimization and correction of the BI-RADS category 4 classification obtained through conventional ultrasound. The objective is to augment both the specificity and accuracy of breast lesion diagnosis, thereby establishing a reliable framework for reducing unnecessary biopsies in clinical settings.
Methods: A cohort comprising 50 cases of breast lesions classified under BI-RADS category 4 was collected during the period from November 2022 and November 2023. These cases were examined utilizing strain elastography (SE), shear wave elastography (SWE), and CEUS. Novel scoring methodologies for ultrasonic elastography (UE) and CEUS were formulated for this investigation. Subsequently, the developed UE and CEUS scoring systems were used to refine and optimize the conventional BI-RADS classification, either in isolation or in conjunction. Based on the revised classification, the benign group was classified as category 3 and the suspected malignant group was classified as category 4a and above, with pathological results serving as the definitive reference standard. The diagnostic efficacy of the optimized UE and CEUS, both independently and in combination, was meticulously scrutinized and compared using receiver operating characteristic (ROC) curve analysis, with pathological findings as the reference standard.
Results: Within the study group, malignancy manifested in 11 cases. Prior to the implementation of the optimization criteria, 78% (39 out of 50) of patients underwent biopsies deemed unnecessary. Following the application of optimization criteria, specifically a threshold of≥8.5 points for the UE scoring method and≥6.5 points for the CEUS scoring method, the incidence of unnecessary biopsies diminished significantly. Reduction rates were observed at 53.8% (21 out of 39) with the UE protocol, 56.4% (22 out of 39) with the CEUS protocol, and 89.7% (35 out of 39) with the combined UE and CEUS optimization protocols.
Conclusion: The diagnostic efficacy of conventional ultrasound BI-RADS category 4 classification for breast lesions is enhanced following optimized correction using UE and CEUS, either independently or in conjunction. The application of the combined protocol demonstrates a notable reduction in the incidence of unnecessary biopsies.
Keywords: BI-RADS 4 categories; breast lesions; contrast-enhanced ultrasound; elastography; optimization correction; scoring method.