Abdominal Injury Clinical Trial
Official title:
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Verified date | May 2024 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 68 |
Est. completion date | July 30, 2024 |
Est. primary completion date | May 9, 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 |
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 |
Lead Sponsor | Collaborator |
---|---|
David Mooney |
United States,
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. |
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