[Translation] A prospective, randomized, controlled, open, multicenter Phase III clinical trial using SonoVue® as a positive control to evaluate the efficacy and safety of injectable perfluoropropane microbubble ultrasound contrast imaging in the diagnosis of focal liver lesions
主要目的:证明注射用全氟丙烷微泡超声造影(CEUS)成像用于肝脏局灶性病变(FLL)良恶性鉴别诊断的敏感度非劣效于声诺维®。次要目的:比较注射用全氟丙烷微泡和声诺维®用于多发性FLL诊断提供更多诊断信息的能力;比较注射用全氟丙烷微泡和声诺维®用于FLL良恶性鉴别诊断的特异度、准确度;比较注射用全氟丙烷微泡和声诺维®的安全性;
[Translation] Primary objective: To demonstrate that the sensitivity of perfluoropropane microbubble injection contrast-enhanced ultrasound (CEUS) imaging for differential diagnosis of benign and malignant focal liver lesions (FLL) is non-inferior to SonoVue®. Secondary objectives: To compare the ability of perfluoropropane microbubble injection and SonoVue® to provide more diagnostic information for the diagnosis of multiple FLLs; To compare the specificity and accuracy of perfluoropropane microbubble injection and SonoVue® for differential diagnosis of benign and malignant FLLs; To compare the safety of perfluoropropane microbubble injection and SonoVue®;