NCT03335566

An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Liver Lesions

Interventions

Type	Name	Description
DRUG	Sonazoid™	Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.
DRUG	SonoVue®	Single Dose of SonoVue® 2.4 mL as I.V. injection.

Timeline

• Start date: 2014-05-11
• Primary completion: 2015-04-09
• Completion: 2015-04-09
• First posted: 2017-11-07
• Last updated: 2018-10-31
• Results posted: 2018-08-27

Locations

18 sites across 3 countries: China, South Korea, Taiwan