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

• Status: Terminated
• Trial end date: 2019-10-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Mooney

Criteria

Inclusion Criteria:

• Hemodynamically stable, as determined by the trauma team

• Age 8 through 17 years

• Interpretable CT of the abdomen and pelvis that demonstrates at least one abdominal solid organ injury among the liver, spleen, pancreas, and kidneys

• Plan for observation or admission to the hospital

• Candidate for abdominal ultrasound based on body habitus

• Have a Glasgow Coma Score of 15

• Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

• Known cardiac abnormality

• Pulmonary hypertension

• Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid

• Unable to roll over

• Unable to assent

• Pregnant

• Lactating

• CT images not available for transmission to central image repository