At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multicentre, Randomised, Comparative Study of the Efficacy and Safety of the Ultrasound Contrast Agents Sonazoid™ and SonoVue® in Subjects With Focal Liver Lesions Undergoing Pre- and Post-Contrast Ultrasound Imaging
In Brief
A Phase 3 clinical trial evaluating Sonazoid™ and SonoVue® for Liver Lesions. Completed, enrolled 424 participants across 18 sites in 3 countries.
Detailed Summary
The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).
Study Details
Timeline
Interventions
Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.
Single Dose of SonoVue® 2.4 mL as I.V. injection.