Effectiveness of Contrast-Enhanced Ultrasound

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children

Conditions
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Abdominal Injuries, Physical Abuse, Accidental Fall, Motor Vehicle Injury

Intervention / Treatment
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* Drug: Contrast-Enhanced Ultrasound using Lumason


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Retrospective Review<br>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). | |
| No Intervention: Prospective Observation<br>Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care. | |
| Other: Contrast-Enhanced Ultrasound using Lumason<br>Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason. | Drug: Contrast-Enhanced Ultrasound using Lumason<br>* Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound<br>* Other names: US Patent No. 5,686,060;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age | To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma. | 2 years | 
| Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age | To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma. | 2 years |