drugset / Trial / NCT00829413

SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization

NCT00829413

Phase 3 Completed 353 enrolled Bracco Diagnostics, Inc
NaSingle-groupOpen-labelDiagnostic

Summary

The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.

Timeline

Start
2010-06
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumason Diagnostic / imaging agent 2.4 ml Intravenous