Effectiveness of Contrast-Enhanced Ultrasound

Phase 4Active Not RecruitingNCT03473249

Children's Hospital of Philadelphia120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Abdominal Injuries

Eligibility

Sex: ALLMin age: 0 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.