Status:
ACTIVE_NOT_RECRUITING
Effectiveness of Contrast-Enhanced Ultrasound
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Abdominal Injuries
Physical Abuse
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this st...
Detailed Description
Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is...
Eligibility Criteria
Inclusion
- Inclusion Criteria for study CEUS
- Males or females \< 8 years of age at time of enrollment
- Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
- Abdominal CT ordered or obtained
- IV in place
- Exclusion Criteria for study CEUS
- Unable to obtain contrast-enhanced ultrasound within 72 hours after CT
- History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
- Known congenital or acquired heart disease
- Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care
- Inclusion criteria:
- Males or females \< 8 years of age at time of CEUS.
- Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma
- Clinical Team plans to perform (or has performed) CEUS as part of clinical care
- Date of CEUS after January 1, 2015
- Exclusion Criteria: None
Exclusion
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03473249
Start Date
May 9 2018
End Date
December 1 2026
Last Update
December 24 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104