NCT00829413

SonoVue®-Enhanced Ultrasound (US) 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 Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (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 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.

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®	SonoVue (2.4 mL)

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-01-27
• Last updated: 2018-08-03
• Results posted: 2018-08-03

Locations

1 site across 1 country: United States