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

NCT04718441 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: P00035263
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Abdominal Injury

Keywords

Solid Organ Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Organ-specific CEUS/CT Concordance

  At the time the CEUS is performed, within 48 hours of injury

• Grade-specific Overall CEUS/CT Concordance

  At the time the CEUS is performed, within 48 hours of injury

• Peritoneal Fluid CEUS/CT Concordance

  At the time the CEUS is performed, within 48 hours of injury.

• Real-time/Centralized CEUS Concordance

  At the time the CEUS is performed, within 48 hours of injury.

Study Arms (1)

All Study Participants

EXPERIMENTAL

All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL

Drug: Lumason

Interventions

Lumason DRUG

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.

Also known as: SonoVue

All Study Participants

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Hemodynamically stable, as determined by the trauma team
• Age 8 through 18 years (inclusive)
• Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys
• Plan for observation or admission to the hospital
• Candidate for abdominal ultrasound based on body habitus, as determined by the investigator
• Glasgow Coma Score of 15
• Able to complete the study procedures within 48 hours of injury

You may not qualify if:

• Known cardiac abnormality
• Pulmonary Hypertension
• Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
• Unable to be rolled onto side to allow lateral ultrasound windows if necessary
• Unable to assent or consent
• Pregnant
• Lactating
• CT images not available for transmission to central image repository

Sponsors & Collaborators

• David Mooney: lead

Study Sites (5)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02118, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Abdominal Injuries

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• David Mooney, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Trauma Program

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: May 10, 2021
• Primary Completion: May 9, 2025
• Study Completion: July 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (5)