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Needle-Free scans could spot silent liver damage

NCT ID NCT03572465

Diagnosis Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Nonalcoholic fatty liver disease affects many people with obesity or type 2 diabetes, and its more serious form, nonalcoholic steatohepatitis, can lead to cirrhosis and liver failure. Doctors currently rely on liver biopsy to judge how severe the disease is, but that test is invasive and carries small risks. Researchers are testing advanced ultrasound techniques that measure fat, inflammation and scarring in the liver without a needle. The study compares these scan results with biopsy findings in adults who have or may have fatty liver disease, and in healthy volunteers.

What this could mean

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

Active substance
quantitative ultrasound imaging techniques, including acoustic radiation force impulse and magnetic resonance elastography
What this could lead to
If it works, doctors could one day assess fatty liver disease with a safe scan instead of a needle biopsy, making it easier to catch serious liver damage early.
What could go wrong
Ultrasound scores may not match biopsy results closely enough, and the technique still needs testing in larger groups before it could replace biopsy in routine care.

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 102 people

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

Started

Oct 2019

Expected to finish

Feb 2027

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

The target population is adults with NAFLD or NASH and healthy volunteers (non-NAFLD subjects). For the purpose of this study, we will recruit NAFLD or NASH patients seen at the hepatology clinic of CHUM, a tertiary care center, and from the McGill University Health Centre (MUHC). Non-NAFLD volunteers will be recruited at the CHUM among the personnel.

Ages

18 years and older

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: * Are at least 18 years old at screening; * Able to comprehend and willingness to provide voluntary consent; * Understand French or English; * NAFLD/NASH subjects: * Have a suspected or known NAFLD or NASH; * Must undergo a liver biopsy as part of their clinical standard of care * Non-NAFLD volunteers: * Do not have a suspected or known NAFLD or NASH Exclusion Criteria: * Are pregnant or trying to become pregnant; * Have a weight or girth preventing them from entering the MR magnet bore; * Are unable to understand or unwilling to provide written informed consent for this study; * Non-NAFLD volunteers: * Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption \>60g of alcohol per day, lipogenic medication and body mass index \>25 kg/m2); * Have a liver steatosis (defined as MRI-proton density fat fraction \<5%); * NAFLD/NASH subjects: * Have other causes of chronic liver disease; * Have a liver transplant

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Conditions

The condition(s) this trial relates to.

allergic disease Fibrosis metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Nonalcoholic fatty liver disease (NAFLD) Nonalcoholic steatohepatitis (NASH)

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

  • Centre Hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

More trials for these conditions

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