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

Gå till den engelska sidan

A new MRI technique could see inside the Liver's metabolism without a biopsy

NCT ID NCT06176079

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This pilot study is testing whether a specialized MRI technique using hyperpolarized pyruvate can non-invasively detect metabolic changes in the liver that are linked to fatty liver disease. The study will include people with simple fatty liver (NAFL), those with the more advanced form (NASH), and healthy volunteers. The goal is to optimize the imaging method and see if it can distinguish between these groups, which could eventually lead to a safer alternative to liver biopsies.

What this could mean

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

Active substance
Hyperpolarized 13C pyruvate and 13C-urea, injected intravenously, used with MRI to image liver metabolism
What this could lead to
If successful, this imaging approach could offer a non-invasive way to detect and monitor fatty liver disease progression, potentially reducing the need for biopsies.
What could go wrong
This is an early pilot study focused on optimizing imaging techniques, not a treatment. The metabolic signals may not clearly distinguish between disease stages, and the approach requires specialized equipment and expertise.

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

44 people

The number who actually took part.

Started

Jul 2020

Finished

Aug 2025

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

Adult patients with diagnosed NASH or NAFLD, or adult healthy volunteers.

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: Part 1 (Imaging Optimization): 1. Able and willing to sign informed consent. 2. Age \>= 18 years old at the time of study entry. Part 2 (Pilot Study): * Group 1 (Fatty Liver Patients without NASH): 1. NAFL as determined by either clinical suspicion of fatty liver disease based on: 1. steatosis by imaging or histology, 2. no significant alcohol consumption, 3. absence of coexisting liver disease OR NAFL determined by liver biopsy 3 months prior to the scan, with the presence of fat on histology but absent ballooning or fibrosis. (nonalcoholic steatohepatitis activity score (NAS) \<= 3). 2. Able and willing to sign informed consent. 3. Age ≥ 18 years old at the time of study entry. 4. Alcohol consumption \< 2 drinks/day for men and \<1 drink/day for women 5. Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody, human immunodeficiency virus (HIV) antibody negative. 6. Serum alanine aminotransferase (ALT) \< 400 microliter (uL) * Group 2 (NASH Patients): 1. NASH as determined by liver biopsy 3 months prior to the scan. a) NASH defined as NAS score greater than or equal to 4 with confirmation of NASH by an anatomic pathologist. 2. Able and willing to sign informed consent. 3. Age \>= 18 years old at the time of study entry. 4. Alcohol consumption \< 2 drinks/day for men and \<1 drink/day for women 5. HBsAg, HCV antibody, HIV antibody negative. * Group 3 (Healthy volunteer): 1. No known history of diabetes or liver disease. 2. Able and willing to sign informed consent. 3. Age \>= 18 years old at the time of study entry. 4. Body mass index \< 25. 5. Liver panel normal (aspartate aminotransferase (AST), ALT, alkaline phosphatase, bilirubin). 6. HBsAg, HCV antibody, HIV antibody negative. 7. Hemoglobin A1c \< 5.7%. 8. Estimated glomerular filtration rate (eGFR) \>= 60 mL/min/1.73m\^2 Exclusion Criteria: Part 1 (Imaging Optimization): For Cohorts 1/B only: 1. Poorly controlled hypertension, with blood pressure at study entry \> 160 mmHg systolic or \> 100 mmHg diastolic. 2. Congestive heart failure with New York Heart Association (NYHA) status ≥ 2. 3. Pregnant or nursing. 4. Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including participants with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. 5. Participant size too large to fit in MR scanner. Part 2 (Pilot Study): All groups 1. Poorly controlled hypertension, with blood pressure at study entry \> 160 mmHg systolic or \> 100 mmHg diastolic. 2. Current treatment with oral medication for diabetes. 3. Pregnant or nursing. 4. Participants unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. 5. Participant size too large to fit in MR scanner. 6. Congestive heart failure with New York Heart Association (NYHA) status \>= 2.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for NAFLD are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

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