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Could a simple ultrasound replace CT scans for injured kids?

NCT ID NCT03473249

Diagnosis Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether contrast-enhanced ultrasound (CEUS) can accurately detect internal abdominal injuries in children under 8 who have experienced blunt trauma, such as from falls or car accidents. Researchers will compare CEUS results to standard CT scans in 120 children. If CEUS proves reliable, it could reduce children's exposure to radiation from CT scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lumason (sulfur hexafluoride microbubbles for injection)
What this could lead to
If successful, this could offer a safer, radiation-free alternative to CT scans for diagnosing abdominal injuries in young children after trauma.
What could go wrong
This is a small pilot study with only 120 children, and results may not apply to all cases. The ultrasound may miss some injuries that CT would detect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 7 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for study CEUS 1. Males or females \< 8 years of age at time of enrollment 2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour) 3. Abdominal CT ordered or obtained 4. IV in place Exclusion Criteria for study CEUS 1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT 2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid) 3. Known congenital or acquired heart disease Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care Inclusion criteria: 1. Males or females \< 8 years of age at time of CEUS. 2. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma 3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care 4. Date of CEUS after January 1, 2015 Exclusion Criteria: None

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Conditions

The condition(s) this trial relates to.

Abdominal Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal injuries Accidental fall Motor vehicle injury Physical abuse

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.