A Phase 3 Multicentre, Randomised, Comparative Study of the Efficacy and Safety of Sonazoid and SonoVue in Subjects with Focal Liver Lesions Undergoing Pre- and Post-Contrast Ultrasound Imaging

Abstract

To compare the efficacy and safety of SonazoidTM and SonoVue® in subjects with focal liver lesions (FLLs). The study was conducted at 17 centres in China and Korea. A total of 424 subjects were randomised to receivea single injection of either Sonazoid (0.12 μL microbubbles/kg) or SonoVue (2.4 mL) for contrast-enhanced ultrasound (CEUS) assessment scans. Three blinded readers evaluated the pre- and post-contrast images.Contrast-enhanced CT (CE-CT), CE-MRI, or biopsy provided the reference diagnosis. Safety variables were assessed4 hours after injection, with follow-up at 24 and 72 hours. There was statistically significant improvement in specificity with Sonazoid for all 3 Readers (p=0.0093) and for Reader 1 (p=0.0023) and Reader 2 (p=0.034) with SonoVue in target focal liver lesion diagnosis as benign or malignant. There was a statistically significant improvement in accuracy for Reader 2(p=0.033) with Sonazoid and for Reader 1(p=0.012) with SonoVue. Sensitivity was generally somewhat higher pre-contrast than post contrast for both Sonazoid and SonoVue. Across all 3 readers Sonazoid and SonoVue were similar in diagnosing FLLs as benign or malignant. Treatment-Emergent AEs (TEAEs) were recorded for 55 (13%) of subjects and the majority were mild in intensity. No serious AEs or deaths occurred in this study. This study indicated that the efficacy of Sonazoid in diagnosing FLLs as benign or malignant was similar to that of SonoVue. Both contrast agents were well tolerated.