drugset / Trial / NCT03147690
Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
NaSingle-groupOpen-labelDiagnostic
Summary
This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.
Timeline
- Start
- 2017-11-01
- Primary completion
- 2019-10-07
- Completion
- 2019-10-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumason | Diagnostic / imaging agent | 0.03 ml | Intravenous |
Indications
No indication recorded.