SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
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.
Timeline
- Start
- 2010-06
- Primary completion
- 2013-07
- Completion
- 2013-07
Outcome
Mixed primary results
registry p <.0001; Difference in Sensitivity (%) 37.8 (95% CI 27.4 to 48.2) NCT00829413 ↗
registry Offsite Reader 1 UE-US vs Offsite Reader 1 SonoVue CE-US; p = 0.1380; Difference in Specificity (%) 7.9 (95% CI -2.4 to 18.2); McNemar NCT00829413 ↗
registry Offsite Reader 2 UE-US vs Offsite Reader 2 SonoVue CE-US; p <.0001; Difference in Specificity (%) 28.6 (95% CI 19.7 to 37.5); McNemar NCT00829413 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumason | Diagnostic / imaging agent | 2.4 ml | Intravenous |