Effectiveness of Contrast-Enhanced Ultrasound

Children's Hospital of Philadelphia (CHOP)

Status and phase: Active, not recruiting; Phase 4

Conditions: Motor Vehicle Injury; Abdominal Injuries; Accidental Fall; Physical Abuse

Treatments: Drug: Contrast-Enhanced Ultrasound using Lumason

Study type: Interventional

Funder types: Other

Identifiers

NCT03473249

17-014183

Details and patient eligibility

About

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.

Full 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 Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed.

This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Retrospective Review

No Intervention group

Description:

Comparison of CT and CEUS results from retrospective chart review of children who have had a CEUS for trauma at the Children's Hospital of Philadelphia (CHOP).

Prospective Observation

No Intervention group

Description:

Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.

Contrast-Enhanced Ultrasound using Lumason

Other group

Description:

Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.

Treatment:

Drug: Contrast-Enhanced Ultrasound using Lumason