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Could a simple ultrasound replace risky scans for kids with Crohn's?

NCT ID NCT03492944

Diagnosis Sponsor: Children's Hospital Medical Center, Cincinnati 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares contrast-enhanced ultrasound to standard CT and MRI scans for detecting bowel inflammation in children aged 10–18 with Crohn's disease. Participants receive an ultrasound with a microbubble contrast agent alongside their regularly scheduled CT or MRI. The goal is to see if the ultrasound can accurately identify and measure inflammation, potentially offering a safer, radiation-free alternative for monitoring disease activity.

What this could mean

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

Active substance
Ultrasound Microbubble Contrast Agent (Lumason)
What this could lead to
If ultrasound works as well as CT or MRI, children with Crohn's could avoid radiation and sedation during routine scans.
What could go wrong
This is a small early study (25 children) comparing imaging methods, not testing a treatment. Ultrasound may not be as accurate as standard scans.

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.

Participants

25 people

The number who actually took part.

Started

Mar 2020

Finished

Oct 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.

Who is studied

We plan to recruit approximately 25 subjects, 10-18 years of age, with known small bowel Crohn disease undergoing clinically indicated Computed Tomography Enterography (CTE) or Magnetic Resonance Enterography (MRE)imaging

Ages

10 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: * histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation \[either CT or MRI\] and receiving medical therapy for Crohn's disease). * Between ages 10 and 18 years. * Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment Exclusion Criteria: * Patients under the age of 10 or over the age of 18. * Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential. * Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2 * Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation. * Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert). * Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR \<30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn disease

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

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