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Could a simple ultrasound replace liver biopsies for kids?

NCT ID NCT07202910

Diagnosis Sponsor: Sahlgrenska University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether special ultrasound scans can accurately detect liver damage in children without needing a needle biopsy. Researchers will compare these scans to standard biopsy results in 550 children with various liver conditions. If the scans prove reliable, they could offer a safer, painless way to monitor liver health.

What this could mean

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

Active substance
ultrasound imaging (shear wave elastography, shear wave dispersion, attenuation imaging)
What this could lead to
If successful, this could allow doctors to diagnose and monitor liver disease in children using a simple ultrasound instead of a needle biopsy.
What could go wrong
This is an early validation study, not a treatment trial. The imaging methods may not be accurate enough to replace biopsies in all cases.

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

About 550 people

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

Started

Mar 2019

Expected to finish

Dec 2032

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.

Who is studied

All participants are children at Queen Silvias Children's hospital, meeting the eligible criteria Study 1-(main study): All children referred for a liver biopsy Study 2a: All children with cystic fibrosis Study 2b: All children liver transplanted Study 2c: All children monitored for intenstinal failiure Study 2d: All children treated with either bariatric surgery or novel appetite-regulating drugs (GLP1 analogues) Study 3: Children who are participating in study 1 and 2, in whom MRI is clinically indicated as a supplement to ultrasound examination - for example, children with obesity for whom ultrasound may be insufficient

Ages

Up to 25 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 (Study 1-main study) * all patients scheduled for a clinically liver biopsy at the Queen Silvia Children's Hospital * any form of suspected or confirmed liver disease * age between 0-18 years * consent by the child/parents to participate. * For controls: children scheduled for a renal biopsy * age between 0-18 years * consent by the child/parents to participate. Exclusion Criteria: * technical limitations regarding the measurements * inability to fully understand the informed consent documents.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities cystic fibrosis-related liver disease Digestive System Diseases intestinal failure–associated liver disease liver disorder metabolic dysfunction-associated steatotic liver disease Obesity Overweight

As listed by the trial registrant

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

Cystic fibrosis liver disease Hepatic disorders Intestinal failure-associated liver disease MAFLD Pediatric liver transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden

    RECRUITING

    Gothenburg, Västra Götaland County, 41650, Sweden

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