Clinical trial NCT04718441: Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Official title: Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Abdominal Injury
Keywords: Solid Organ Injury
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 68
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall CEUS/CT Concordance for all study participants
timeFrame: At the time the CEUS is performed, within 48 hours of injury
Secondary outcomes:
measure: Organ-specific CEUS/CT Concordance
timeFrame: At the time the CEUS is performed, within 48 hours of injury
measure: Grade-specific Overall CEUS/CT Concordance
timeFrame: At the time the CEUS is performed, within 48 hours of injury
measure: Peritoneal Fluid CEUS/CT Concordance
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
measure: Real-time/Centralized CEUS Concordance
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Boston Children's Hospital
name: David Mooney, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: