Clinical trial

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

Name

17-014183

Description

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.

Trial arms

Trial start

2018-05-09

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Contrast-Enhanced Ultrasound using Lumason

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

Arms:

Contrast-Enhanced Ultrasound using Lumason

Other names:

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

Size

120

Primary endpoint

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

2 years

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

2 years

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-12-28

1 organization

1 product

4 indications

Organization

Children's Hospital of Philadelphia

Product

Contrast-Enhanced Ultrasound using Lumason

Indication

Indication

Indication

Indication