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Can a scan replace the needle? ultrasound and MRI put to the test against liver biopsy for fatty liver disease

NCT ID NCT04785937

Diagnosis Sponsor: Azienda USL Reggio Emilia - IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study investigates whether non-invasive imaging techniques—ultrasound and MRI—can accurately diagnose non-alcoholic steatohepatitis (NASH) and liver fibrosis in people with fatty liver disease. Currently, a liver biopsy is the gold standard, but it is invasive and carries risks. The trial enrolls patients who already need a biopsy and compares imaging results to the biopsy findings, aiming for at least 90% accuracy. If successful, these imaging methods could offer a safer, more practical way to identify patients who might benefit from future NASH treatments.

What this could mean

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

Active substance
ultrasound and magnetic resonance imaging
What this could lead to
If these imaging methods prove accurate enough, they could replace invasive liver biopsies for diagnosing NASH and fibrosis, making diagnosis safer and more accessible.
What could go wrong
This is a small, early-stage diagnostic study with only 28 participants. The imaging tests may not reach the 90% accuracy target, and results may not apply to all NAFLD 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Jan 2019

Finished

Jun 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * clinical indication to perform a liver biospy for NAFLD assessment based on all of the following: 1. presence of liver steatosi at ultrasound 2. at least one risk factor for NASH/fibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome) 3. increased liver enzymes (at least one of: GOT\>40 U/l, GPT\>49 U/l, GGT\>75 U/l) or high NAFLD fibrosis score (\>0.675), or intermediate NAFLD fibrosis score (between -1.455 and 0.675) and increased liver stiffness at transient elastography (\>7 KPa). * consent to participate in the study Exclusion Criteria: * age \< 18 years * secondary causes of liver steatosis (moderate to severe alcohol consumption, steatogenic drugs) * known diffuse liver diseases other than NAFLD (cirrhosis, viral or autoimmune hepatitis, hemochromatosis, amiloidosis, other) or previous primary or secondary liver neoplasms * contraindications to perform liver biopsy (ascites, platelet count\<50.000/mmc, INR\>1.5, PT\>50%, serum bilirubin \>3 mg/dL) * contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease 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.

Liver fibroses Non-alcoholic fatty liver disease Steatohepatitis, nonalcoholic

Contacts and locations

Locations

  • Azienda USL-IRCCS di Reggio Emilia

    Reggio Emilia, RE, 42123, Italy

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