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Could a simple MRI spare young patients from invasive liver biopsies?

NCT ID NCT03175471

Knowledge-focused Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is testing whether MRI scans can accurately detect bile duct damage and liver scarring in young people aged 6 to 23 with autoimmune liver diseases like primary sclerosing cholangitis and autoimmune hepatitis. Researchers will compare MRI results with traditional liver biopsy findings and blood tests to see if the scans can serve as a reliable, non-invasive alternative. If successful, this could make monitoring the disease much easier and less painful for patients.

What this could mean

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

Active substance
MRI-based imaging (MRCP and MR elastography) as a non-invasive diagnostic tool
What this could lead to
If MRI proves reliable, it could reduce the need for invasive liver biopsies in young patients with autoimmune liver disease.
What could go wrong
This is an observational study, not a treatment trial. MRI findings may not perfectly match biopsy results, and the study is limited to a specific age group and disease types.

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 115 people

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

Started

Jan 2017

Expected to finish

Jan 2030

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

A total of 115 patients between 6 and 23 years of age with a diagnosis of PSC or AIH will be enrolled.

Ages

6 to 23 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. Age 6-23 years old. 2. Established or suspected clinical diagnosis of AIH or PSC. Exclusion Criteria: 1. History of liver transplantation. 2. Chronic Hepatitis B or untreated hepatitis C virus infection. 3. Pregnancy. 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia). 5. Diagnosis of cystic fibrosis or biliary atresia 6. Diagnosis of cardiac hepatopathy. 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease. 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

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

Autoimmune hepatitis Autoimmune liver disease Primary sclerosing cholangitis

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

  • Cincinnati Childrens Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

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