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Could a simple ultrasound replace CT scans for kids with belly injuries?

NCT ID NCT04718441

Diagnosis Sponsor: David Mooney 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether contrast-enhanced ultrasound (CEUS) can accurately find solid organ injuries in children's abdomens after trauma. 68 children aged 8-18 who already had a CT scan showing an injury received an ultrasound with and without a contrast agent called Lumason. The goal was to see if CEUS results matched the CT findings, potentially offering a radiation-free alternative for diagnosis.

What this could mean

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

Active substance
Lumason (contrast agent)
What this could lead to
If successful, this could provide a safer, radiation-free way to diagnose abdominal injuries in children, reducing reliance on CT scans.
What could go wrong
This is an early-phase study with only 68 participants, so results may not apply to all children. The accuracy of CEUS may vary depending on injury type and patient factors.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

68 people

The number who actually took part.

Started

May 2021

Finished

Jul 2025

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

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 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

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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 injury

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02118, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84113, United States

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