Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS)
in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will
complete the study across approximately 5-10 sites in the US, with up to 30 patients in the
training phase (3 per site) and 100 patients in the treatment phase of the study. All
subjects will have had a CT scan as part of standard of care, confirming at least one solid
organ abdominal injury. The study procedure will occur within 48 hours from time of 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 CT and
ultrasound scans will be read locally and will undergo central review.