CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 349 enrolled
Drug / intervention
SonoVue-enhanced ultrasound +1 moredrug
Likely dose
SonoVue-enhanced ultrasound 2.4 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00788697
NCT00788697Phase 3Completed
CompareCT.gov

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

Bracco Diagnostics, Inc·interventional·Posted Nov 11, 2008·Updated Dec 12, 2017

In Brief

A Phase 3 clinical trial evaluating SonoVue-enhanced ultrasound and Unenhanced ultrasound for Liver Neoplasms. Completed, enrolled 349 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2008
Enrollment StartSep 1, 2009
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.6 years ago

Interventions

SonoVue-enhanced ultrasounddrug

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)

Unenhanced ultrasoundother

-Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None