drugset / Trial / NCT03335566

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

NCT03335566

Phase 3 Completed 424 enrolled GE Healthcare
RandomizedParallel-groupOpen-labelDiagnostic

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).

Timeline

Start
2014-05-11
Primary completion
2015-04-09
Completion
2015-04-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lumason Diagnostic / imaging agent 2.4 ml Intravenous
Subject Perflubutane Diagnostic / imaging agent 0.12 unknown Intravenous

Indications