Effectiveness of Contrast-Enhanced Ultrasound

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: The Ray E. Helfer Society

Criteria

Inclusion Criteria for study CEUS

1. Males or females < 8 years of age at time of enrollment

2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)

3. Abdominal CT ordered or obtained

4. IV in place

Exclusion Criteria for study CEUS

1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT

2. 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)

3. 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:

1. Males or females < 8 years of age at time of CEUS.

2. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma

3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care

4. Date of CEUS after January 1, 2015

Exclusion Criteria: None