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A liver scan that could foretell the future?

NCT ID NCT07777198

Knowledge-focused Sponsor: Beijing Friendship 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This observational study looks at whether changes in liver stiffness, measured by a device called iLivTouch, can predict serious liver-related events and death in people with fatty liver disease that has progressed to advanced scarring. The study follows over 2,000 adults with this condition, tracking their liver stiffness over time. The goal is to see if these measurements can help identify who is at higher risk, potentially guiding earlier and more personalized care.

What this could mean

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

Active substance
iLivTouch device for liver stiffness measurement
What this could lead to
If successful, this could lead to a non-invasive way to predict which MAFLD patients are at higher risk of liver complications, helping guide treatment decisions.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may not apply to all patients, and the predictive accuracy might be limited.

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 2,303 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

Multicenter retrospective real-world cohort of adult patients (≥18 years) with MAFLD-related compensated advanced chronic liver disease (cACLD, LSM1 ≥10 kPa per Baveno-VII consensus). Participants must have at least two LSM measurements ≥12 months apart. Patients with competing chronic liver diseases, excessive alcohol consumption, malignancies, TIPS history, acute liver injury and other predefined conditions are excluded from this study.

Ages

18 years and older

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. Aged ≥18 years, both male and female. 2. Clinically diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and progressed to compensated advanced chronic liver disease (cACLD) according to the 2024 Chinese Guidelines for the Management of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease. cACLD is defined as baseline liver stiffness measurement (LSM1) ≥10 kPa based on the Baveno-VII consensus. 3. At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements. Exclusion Criteria: 1. Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc. 2. Weekly alcohol intake ≥210 g for men or ≥140 g for women. 3. Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value. 4. Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value. 5. Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value. 6. Presence of vascular liver disease, cystic fibrosis-related liver disease, sarcoidosis, polycystic liver disease, congenital or rare inherited liver disease, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure complicated by hepatic venous congestion. 7. History of transjugular intrahepatic portosystemic shunt (TIPS). 8. Acute hepatitis (alanine aminotransferase \>5-fold upper limit of normal) or acute-on-chronic liver failure (ACLF) occurring at the time of LSM1 or LSMC measurement. 9. Missing value of either LSM1 or LSMC. 10. Any other conditions judged by investigators to be inappropriate for study participation.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

MAFLD

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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