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

Stopped early · Phase 1/Phase 2

Conditions studied: Abdominal Injury

In brief

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.

Key facts

Study ID

NCT03147690

Run by

David Mooney

People needed

74

Starts

2017-11-01

Expected to finish

2019-10-07

Last updated by the study team

2021-06-11

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Lucile Packard Children's Hospital — Palo Alto, California, United States
• Riley Children's Health — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's — Columbus, Ohio, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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