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Completed

NCT Number: NCT04718441

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.

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Key information

Conditions

Abdominal Injury Abdominal Injuries Wounds and Injuries

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: SonoVue

Primary outcomes

  1. Overall CEUS/CT Concordance for all study participants

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

    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.

Secondary outcomes

  1. Organ-specific CEUS/CT Concordance

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

    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.

  2. Grade-specific Overall CEUS/CT Concordance

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

    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.

  3. Peritoneal Fluid CEUS/CT Concordance

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

    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.

  4. Real-time/Centralized CEUS Concordance

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

    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.

Sponsors and collaborators

Lead sponsor

David Mooney

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2021
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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