CEUS for Blunt Abdominal Trauma in Children

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT03490929
Phase
PHASE4
Status
Recruiting

Conditions

  • Trauma Abdomen

Eligibility Criteria

Sex
ALL
Age
0 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] — DRUG
    injection of Lumason (ultrasound contrast agent)
  • contrast-enhanced ultrasound — DEVICE
    ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Study Details

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.

Key Dates

Start date
Jun 1, 2018
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
146 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Contrast-enhanced ultrasound arm
    contrast-enhanced ultrasound

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Tobias Kummer, MD
507-255-4732
Derek Vanmeter
5072554732
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Aaron E Chen, MD
267-426-0383
Tobias Kummer, MD (PRINCIPAL_INVESTIGATOR)

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