Recruiting

CEUS

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT03490929

Conditions

Trauma Abdomen

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

contrast-enhanced ultrasound

Study Details

Brief summary:

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Conditions

Trauma Abdomen

Study ID

NCT03490929

Start date

Jun 1, 2018

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
2. History of or suspicion for blunt abdominal trauma
3. Abdominal CT ordered or obtained

Exclusion Criteria:

1. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
2. Co-existing penetrating abdominal trauma
3. Known congenital or acquired heart disease

Study Design

Enrollment

146 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Contrast-enhanced ultrasound arm

contrast-enhanced ultrasound

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

injection of Lumason (ultrasound contrast agent)

contrast-enhanced ultrasound

ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Primary outcome measure

  • Sensitivity of CEUS [ Time Frame: through study completion, which is expected to take around 3 years ]
  • Specificity of CEUS [ Time Frame: through study completion, which is expected to take around 3 years ]

Central Contacts and Locations

Central contacts

Aaron E Chen, MD

2674260383chena2@chop.edu

Rachel Rempell, MD

2155907041rempellr@chop.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Tobias Kummer, MD

507-255-4732kummer.tobias@mayo.edu

Derek Vanmeter

5072554732VanMeter.Derek@mayo.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Aaron E Chen, MD

267-426-0383CHENA2@chop.edu

Principal Investigator:

Tobias Kummer, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-12-17.