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

This is an interventional 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. At conclusion of enrollment
of all subjects a centralized review of CT vs. CEUS will occur to compare to real time
readings.

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