Current Environment:

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.

Conditions

Abdominal Injury

Recruitment Status

Terminated

Detailed Description

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.

Eligibility 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

Intervention

Intervention Type

Intervention Name

Drug

Lumason

Phase

Phase 1, Phase 2

Gender

All

Minimum Age

8 Years

Maximum Age

17 Years

Download Date

June 11, 2021

Principal Investigator

David Mooney

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: