A Phase 4 interventional study of Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] and contrast-enhanced ultrasound in Trauma Abdomen, sponsored by Children's Hospital of Philadelphia. Recruiting at 2 sites in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Children's Hospital of Philadelphia · Phase 4, Interventional, and Diagnostic
Among 19 studies in Abdominal Injuries with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Abdominal Injuries · United States.
Among the 19 studies in Abdominal Injuries with a site in United States, this one is the 8th largest by planned enrollment of the 13 interventional ones, is one of 3 that started in 2018, is one of 4 in phase 4, and was the 7th registered.
60 studies on the registry are indexed under Abdominal Injuries; 19 are open to participants now.
This study's planned enrollment of 146 is above the median of 125 across 30 interventional studies indexed under Abdominal Injuries.
Browse Abdominal Injuries studies →5 of the 19 studies in Abdominal Injuries with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 9 Abdominal Injuries studies recruiting now, 5 (56%) set no upper age limit and 4 (44%) stop at 75 or younger; 7 take children under 18; 0 take healthy volunteers.
This study: 0 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2018.
Median enrollment 150 across the 13 interventional studies, 155 across the 6 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
1 of 19 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 2 studies filed under Abdominal Injuries — fewer than ten, so there is no comparison to draw.
5 of the studies in Abdominal Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03473249Children's Hospital of PhiladelphiaEffectiveness of Contrast-Enhanced Ultrasound | 2026-12 |
| NCT03490929Children's Hospital of PhiladelphiaCEUS for Blunt Abdominal Trauma in Children | 2026-12-31 |
| NCT04937868University of California, Los AngelesDeveloping a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients | 2027-01-15 |
| NCT06065202Duke UniversityPersonalized Nutrition to Improve Recovery in Trauma | 2027-03-30 |
| NCT05910567University of California, DavisA Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma | 2027-04-30 |
Among the 19 studies in Abdominal Injuries with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.
In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma
Design:
This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.
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Exclusion Criteria:
contrast-enhanced ultrasound
Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] · Device: contrast-enhanced ultrasound
injection of Lumason (ultrasound contrast agent)
Also known as: Lumason
ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
Also known as: ultrasound
Sensitivity of CEUS
calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT
Time frame: through study completion, which is expected to take around 3 years
Specificity of CEUS
calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam
Time frame: through study completion, which is expected to take around 3 years
Plan to share: Undecided
Started Jun 2018 (actual). Primary completion is estimated for Dec 2026, 102 months after the start.
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Studies of the drug tested here: Sulfur Hexafluoride
Children's Hospital of Philadelphia →