A new MRI technique could see inside the Liver's metabolism without a biopsy
NCT ID NCT06176079
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
44 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Aug 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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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
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University of California, San Francisco
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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