Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

Abdominal Injury Clinical Trial

Official title:

Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718441
• Other study ID #: P00035263
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 10, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: Boston Children's Hospital
• Contact: Danielle Crethers
• Phone: 617-919-6325
• Email: Danielle.crethers[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.

Description:

This is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric trauma patients. Up to 130 subjects will be enrolled across approximately 5 to 10 sites in the US. Each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real-time readings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: March 30, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Hemodynamically stable, as determined by the trauma team

2. Age 8 through 18 years (inclusive)

3. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys

4. Plan for observation or admission to the hospital

5. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator

6. Glasgow Coma Score of 15

7. Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

1. Known cardiac abnormality

2. Pulmonary Hypertension

3. Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid

4. Unable to be rolled onto side to allow lateral ultrasound windows if necessary

5. Unable to assent or consent

6. Pregnant

7. Lactating

8. CT images not available for transmission to central image repository

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Injury

Intervention

Drug:
• Lumason
Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
David Mooney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall CEUS/CT Concordance for all study participants	A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, regardless of injury grade, by the local study site reviewer. Otherwise, a patient is classified as having a "discordant" assessment.	At the time the CEUS is performed, within 48 hours of injury
Secondary	Organ-specific CEUS/CT Concordance	For each organ, a patient's organ is classified as having a "concordant" assessment if the presence or absence of an injury as identified by CT is exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.	At the time the CEUS is performed, within 48 hours of injury
Secondary	Grade-specific Overall CEUS/CT Concordance	A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, AND within 1 grade of the injury as identified by CT. Otherwise, a patient is classified as having a "discordant" assessment.	At the time the CEUS is performed, within 48 hours of injury
Secondary	Peritoneal Fluid CEUS/CT Concordance	A patient is classified as having a "concordant" assessment if the absence or presence of peritoneal fluid identified by CT is also exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.	At the time the CEUS is performed, within 48 hours of injury.
Secondary	Real-time/Centralized CEUS Concordance	A patient is classified as having a "concordant" assessment if the absence or presence of injury for each organ identified by 'real-time' CEUS with injuries is also exactly identified by centralized interpretation of CEUS images.	At the time the CEUS is performed, within 48 hours of injury.