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Contrast Ultrasound for Pediatric Abdominal Injuries

Phase 1 & 2
Recruiting
Led By David Mooney, MD, MPH
Research Sponsored by David Mooney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time the ceus is performed, within 48 hours of injury
Awards & highlights

Study Summary

This trial is testing whether contrast-enhanced ultrasound (CEUS) is accurate in diagnosing abdominal solid organ injuries in pediatric patients. 130 subjects will be recruited from 5-10 sites across the US, with 100 subjects 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

Who is the study for?
The CAPTURE Study is for kids aged 8-18 who've had a CT scan showing at least one solid organ injury in the abdomen from an accident. They must be stable, able to have an ultrasound, not pregnant or lactating, and without heart or lung issues. The study needs to start within 48 hours of their injury.Check my eligibility
What is being tested?
This study tests how well contrast-enhanced ultrasound (CEUS) spots abdominal injuries compared to CT scans in children with trauma. It uses Lumason as a contrast agent during the ultrasound, after which results are matched against existing CT scan data.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to sensitivity to Lumason's ingredients like sulfur hexafluoride and polyethylene glycol. However, specific side effects aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 18 years old.
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My CT scan shows an injury in at least one organ like the liver, spleen, pancreas, or kidneys.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time the ceus is performed, within 48 hours of injury.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time the ceus is performed, within 48 hours of injury. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall CEUS/CT Concordance for all study participants
Secondary outcome measures
Grade-specific Overall CEUS/CT Concordance
Organ-specific CEUS/CT Concordance
Cognitive Therapy
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All Study ParticipantsExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumason
2015
Completed Phase 4
~390

Find a Location

Who is running the clinical trial?

David MooneyLead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Abdominal Injury
74 Patients Enrolled for Abdominal Injury
David Mooney, MD, MPHPrincipal Investigator - Boston Children's Hospital
Boston Children's Hospital, Milford Regional Medical Center
St Louis University School Of Medicine (Medical School)
Fletcher Allen Hlth Care (Residency)
1 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Abdominal Injury
74 Patients Enrolled for Abdominal Injury

Media Library

Lumason Clinical Trial Eligibility Overview. Trial Name: NCT04718441 — Phase 1 & 2
Abdominal Injury Research Study Groups: All Study Participants
Abdominal Injury Clinical Trial 2023: Lumason Highlights & Side Effects. Trial Name: NCT04718441 — Phase 1 & 2
Lumason 2023 Treatment Timeline for Medical Study. Trial Name: NCT04718441 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include elderly participants of 65 years or more?

"This research initiative is seeking to enrol individuals aged 8-18. Clinically, 11 trials are designed for minors and a further 12 studies will involve patient cohorts of 65 years or older."

Answered by AI

Am I eligible for enrollment in this research experiment?

"This trial is recruiting 68 minors between the ages of 8 and 18 who have sustained abdominal trauma. Eligibility criteria include hemodynamic stability, a Glasgow Coma Score of 15, an interpretable CT scan demonstrating one or more solid organ injuries from among the liver, spleen, pancreas and kidneys, candidacy for ultrasound imaging based on body habitus as determined by investigators and ability to complete study procedures within 48 hours post-injury."

Answered by AI

Are there any other published reports concerning the utilization of Lumason?

"Currently, Lumason is being studied in 14 medical studies with 2 trials reaching Phase 3. Throughout the USA, there are 18 different sites that have been recruited to administer this medication. The majority of these locations can be found near Philadelphia, Pennsylvania."

Answered by AI

How many volunteers are participating in this experiment?

"68 individuals who meet the necessary requirements must join this clinical trial. Study sites located in Dallas, Texas and Boston, Massachusetts are available for registration."

Answered by AI

What is the present scope of this medical experiment?

"This clinical trial is available to participating patients at University of Texas Southwestern Medical Center in Dallas, Boston Children's Hospital in Massachusetts and Cincinnati Children's Hospital Medical Centre in Ohio. Additionally, there are an additional 5 medical sites accepting enrolments."

Answered by AI

Are participants still welcome to join this experiment?

"Absolutely. Clinicaltrials.gov attests to the active recruitment for this venture, which was first publicized on May 10th 2021 and most recently updated March 15th 2022. The study is recruiting 68 patients from 5 different locations."

Answered by AI

Does this research venture constitute a pioneering exploration?

"Lumason has been extensively investigated since 2017, when the first research study was funded and conducted by Bracco Diagnostics. This initial trial of 125 participants led to a Phase I drug approval for Lumason. Presently, 14 distinct clinical trials are ongoing in 10 cities across 3 different nations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
David Mooney 2021. "Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718441.
~17 spots leftby Apr 2025
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