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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Injury
• Intervention / Treatment: Drug: Lumason

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Crethers; Phone Number: 617-919-6325; Email: Danielle.crethers@childrens.harvard.edu
• Study Contact Backup: Name: Samarpita Chatterjee; Email: samarpita.chatterjee@childrens.harvard.edukathy.wong@childrens.harvard.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Erin Garvey, MD; Phone Number: 602-933-0016; Email: egarvey@phoenixchildrens.com
      • Principal Investigator: Erin Garvey, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Children's Hospital
      • Principal Investigator: David Mooney, MD, MPH
      • Contact: Danielle Crethers; Phone Number: 617-919-6325; Email: Danielle.crethers@childrens.harvard.edu
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Suzanne Moody, MPA; Phone Number: 513-636-8639; Email: Suzanne.Moody@cchmc.org
      • Principal Investigator: Richard Falcone, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Not yet recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Claire Starcke, B.S.; Phone Number: 214-648-7754; Email: Charlton.Starcke@UTSouthwestern.edu
      • Principal Investigator: Jeannie Kwon, MD
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Not yet recruiting
      • University of Utah
      • Contact: Kezlyn Larsen; Phone Number: 801-662-2989; Email: kezlyn.larsen@hsc.utah.edu
      • Principal Investigator: Katie Russell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Study Participants; 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; 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.; Other Names: SonoVue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.

Collaborators and Investigators

• Sponsor: David Mooney
• Investigators: Principal Investigator: David Mooney, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Solid Organ Injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: P00035263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No