The ability of contrast-enhanced ultrasound with Sonazoid to differentiate endometrial carcinoma from benign endometrial lesions: A preliminary, prospective, and multicenter clinical study.

Objective: To examine the diagnostic efficacy of contrast-enhanced ultrasound (CEUS) with Sonazoid (Sonazoid-CEUS) for endometrial lesions.

Methods: In this prospective and multicenter study, data were collected from 84 patients with endometrial lesions from 11 hospitals in China. All the patients received a conventional US and Sonazoid-CEUS examination. The lesion characteristics based on US and Sonazoid-CEUS imaging were collected from the case report forms. The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were determined using histopathologic diagnosis as the gold standard.

Results: Of the 79 patients included, 29 were diagnosed with benign lesions and 50 with endometrial carcinoma (EC). The accuracy, sensitivity, specificity, PPV, and NPV for Sonazoid-CEUS and US at differentiating EC from benign endometrial lesions were 82.2%, 94%, 62.1%, 81.0%, and 85.7%, and 79.7%, 96%, 51.7%, 92.3%, and 88.2%, respectively, with no significant differences observed for any of the values. For Sonazoid-CEUS, the best delineators of EC versus benign lesions were early enhancement and hyperenhancement (74% vs 53.3%, P = 0.029, 68% vs 45%, P < 0.001), and lesion size enlargement (76% vs 48%, P = 0.001). Despite finding no significant difference in the enhancement patterns (P = .367), a faster wash-in pattern with the contrast agent entering before the surrounding myometrium was more common in the EC vs benign cases (92% vs 48.3%).

Conclusions: Sonazoid-CEUS has higher accuracy, specificity, and comparable sensitivity for differentiating EC from benign endometrial lesions compared with conventional US. It provides complementary hemodynamics information reflective of tissue vascularization, which may improve the overall diagnostic efficiency.