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New ultrasound test could replace liver biopsies for fatty liver patients

NCT ID NCT07530419

Knowledge-focused Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether two different ultrasound machines can accurately measure liver stiffness and inflammation in people with fatty liver disease. About 95 to 100 adults will take part, including healthy liver donors and patients with fatty liver. The goal is to see if these noninvasive scans can replace painful liver biopsies for diagnosing liver damage.

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 95 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

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

Adults aged 18 years or older recruited from Seoul National University Hospital, including (1) living-donor candidates undergoing donor evaluation as a healthy reference cohort, and (2) outpatients with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound.

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: * \[Cohort A - Healthy reference\] * Adults ≥18 years old * Currently undergoing living-donor evaluation at SNUH * Donor evaluation confirms (a) hepatic steatosis \<5% by imaging or biopsy, (b) normal AST/ALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.) * Provided written informed consent \[Cohort B + C - Steatotic liver disease\] * Adults ≥18 years old * Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound * Serum AST/ALT results available within 6 weeks of ultrasound, or scheduled * Provided written informed consent Exclusion Criteria: * • Significant alcohol intake within the past 2 years (\>30-60 g/day for males, \>20-50 g/day for females) * Diagnosed or strongly suspected chronic liver disease (active HBV/HCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.) * Suspected hepatic failure or decompensated cirrhosis (albumin \<3.2 g/dL, INR \>1.3, direct bilirubin \>1.3 mg/dL) * Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible * History of liver malignancy or treatment for liver malignancy * History of liver surgery * Pregnancy or lactation * Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease fibrotic liver disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Fatty liver Liver fibrosis Metabolic dysfunction-associated steatotic liver disease

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

  • Seoul National University Hospital

    Seoul, 03080, South Korea

More trials for these conditions

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