At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 353 enrolled
Drug / intervention
SonoVue®drug
Likely dose
SonoVue® 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.
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
In Brief
A Phase 3 clinical trial evaluating SonoVue® for Liver Neoplasms. Completed, enrolled 353 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Neoplasms
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartJun 2010
Primary CompletionJul 2013
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.4 years ago
Interventions
SonoVue®drug
SonoVue (2.4 mL)