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

Summary

The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.

Timeline

Start

2009-09

Primary completion

2013-07

Completion

2013-07

Outcome

Mixed primary results

registry p = 0.0011; Difference in Sensitivity (%) 19.4 (95% CI 8.3 to 30.5); McNemar NCT00788697 ↗

registry p = 0.0016; Difference in Sensitivity (%) -19.4 (95% CI -30.9 to -7.8); McNemar NCT00788697 ↗

registry p <.0001; Difference in Specificity (%) 47.4 (95% CI 37.4 to 57.4); McNemar NCT00788697 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumason	Diagnostic / imaging agent	2.4 ml	Intravenous

Indications