Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Spleen stiffness scan could spare liver patients painful biopsies

NCT ID NCT07440511

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether measuring spleen stiffness with a special ultrasound probe can detect advanced liver scarring in people with metabolic fatty liver disease (MASLD). Researchers will follow 500 adults for up to several years to see if the test predicts serious liver problems like cirrhosis or liver cancer. The goal is to replace invasive liver biopsies with a quick, painless scan.

What this could mean

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

Active substance
spleen stiffness measurement (non-invasive ultrasound-based test)
What this could lead to
If successful, this could provide a simple, needle-free way to detect advanced liver scarring early and predict complications in people with fatty liver disease.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove accurate enough to replace current methods, and results may not apply to all patients.

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 500 people

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

Started

Jan 2026

Expected to finish

Jan 2033

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 (age \> 18 years) with metabolic dysfunction-associated steatotic liver disease.

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: * Age \> 18 years * Diagnosis of MASLD according to EASL guidelines * Presence of cACLD confirmed by histology (fibrosis F3-F4) or assessed non-invasively (LSM \> 15 kPa), OR suspected cACLD based on non-invasive tests (LSM \> 8 kPa) that leads to or has led to the indication for liver biopsy according to routine clinical practice * Signed informed consent for the prospective cohort Exclusion Criteria: * Other etiologies of liver disease, including viral, autoimmune/cholestatic, drug-induced, alcohol-related liver disease (ALD), or use of hepatotoxic drugs (e.g. long-term oral corticosteroids, estrogen-progestin therapy, methotrexate, valproic acid) * Primary or secondary liver cancer * Previous hepatic decompensation * Hematological disorders * Portal vein thrombosis * Previous TIPS placement * Previous liver transplantation * Current or past extrahepatic malignancy (\< 5 years) * Previous bariatric surgery (\< 3 years)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Masld (metabolic dysfunction-associated steatotic liver disease) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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.

Masld (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

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

More trials for these conditions

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