drugset / Trial / NCT03147690

Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children

NCT03147690

Phase 1/2 Terminated 74 enrolled David Mooney
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

EvaluationDrugModalityDoseRoute
Subject Lumason Diagnostic / imaging agent 0.03 ml Intravenous

Indications

No indication recorded.