A Phase 4 interventional study of Contrast-Enhanced Ultrasound using Lumason in Abdominal Injuries, Physical Abuse and Accidental Fall, sponsored by Children's Hospital of Philadelphia. Active, not recruiting at 1 site in United States. Open to participants aged 0 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
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 9th 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 6th registered.
60 studies on the registry are indexed under Abdominal Injuries; 19 are open to participants now.
This study's planned enrollment of 120 is close to 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 7 Years · all sexes · healthy volunteers too.
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.
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed.
This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.
Inclusion Criteria for study CEUS
Exclusion Criteria for study CEUS
Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care
Inclusion criteria:
Exclusion Criteria: None
Comparison of CT and CEUS results from retrospective chart review of children who have had a CEUS for trauma at the Children's Hospital of Philadelphia (CHOP).
Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
Drug: Contrast-Enhanced Ultrasound using Lumason
Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
Also known as: SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060
Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Time frame: 2 years
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Time frame: 2 years
Plan to share: Undecided
Started May 2018 (actual). Primary completion is estimated for Dec 2026, 103 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia →