NCT00788697

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

Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Conditions

• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	SonoVue-enhanced ultrasound	Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL)
OTHER	Unenhanced ultrasound	-Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2008-11-11
• Last updated: 2017-12-12
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States