Clinical trial

Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children

Name
18-014905
Description
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.
Trial arms
Trial start
2018-06-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
injection of Lumason (ultrasound contrast agent)
Arms:
Contrast-enhanced ultrasound arm
Other names:
Lumason
contrast-enhanced ultrasound
ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
Arms:
Contrast-enhanced ultrasound arm
Other names:
ultrasound
Size
146
Primary endpoint
Sensitivity of CEUS
through study completion, which is expected to take around 3 years
Specificity of CEUS
through study completion, which is expected to take around 3 years
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 146, 'type': 'ESTIMATED'}}
Updated at
2023-12-19

1 organization

1 product

1 indication