drugset / Trial / NCT03335566
An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
RandomizedParallel-groupOpen-labelDiagnostic
Summary
The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).
Timeline
- Start
- 2014-05-11
- Primary completion
- 2015-04-09
- Completion
- 2015-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lumason | Diagnostic / imaging agent | 2.4 ml | Intravenous |
| Subject | Perflubutane | Diagnostic / imaging agent | 0.12 unknown | Intravenous |