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Active, Not Recruiting

NCT Number: NCT03473249

Effectiveness of Contrast-Enhanced Ultrasound

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

0 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-Enhanced Ultrasound using Lumason

Drug

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

Other names: SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060

Primary outcomes

  1. Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age

    Time frame: 2 years

    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. Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2018
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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