Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease
Completed
Conditions studied: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis, NAFLD, NASH
In brief
The recent development of dissolution dynamic nuclear polarization (DNP) technology for hyperpolarized (HP) 13C imaging offers a promising new avenue for non-invasively accessing fundamental metabolic changes associated with the progression of fatty liver disease in vivo. The purpose of this pilot study is to optimize sequence parameters for hyperpolarized 13C acquisition in the human liver and determine which metabolic changes can be seen in humans with simple, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) when compared to healthy volunteers.
Key facts
- Study ID
- NCT06176079
- Run by
- Michael Ohliger, MD PhD
- People needed
- 44
- Starts
- 2020-07-22
- Expected to finish
- 2025-08-28
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Part 1 (Imaging Optimization):
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Part 2 (Pilot Study):
- Group 1 (Fatty Liver Patients without NASH):
- NAFL as determined by either clinical suspicion of fatty liver disease based on:
- steatosis by imaging or histology,
- no significant alcohol consumption,
- 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).
- Able and willing to sign informed consent.
- Age ≥ 18 years old at the time of study entry.
- Alcohol consumption < 2 drinks/day for men and <1 drink/day for women
- Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody, human immunodeficiency virus (HIV) antibody negative.
- Serum alanine aminotransferase (ALT) < 400 microliter (uL)
- Group 2 (NASH Patients):
- 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.
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Alcohol consumption < 2 drinks/day for men and <1 drink/day for women
- HBsAg, HCV antibody, HIV antibody negative.
- Group 3 (Healthy volunteer):
- No known history of diabetes or liver disease.
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
You may not qualify if…
- Part 1 (Imaging Optimization): For Cohorts 1/B only:
- Poorly controlled hypertension, with blood pressure at study entry > 160 mmHg systolic or > 100 mmHg diastolic.
- Congestive heart failure with New York Heart Association (NYHA) status ≥ 2.
- Pregnant or nursing.
- 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.
- Participant size too large to fit in MR scanner.
- Part 2 (Pilot Study): All groups
- Poorly controlled hypertension, with blood pressure at study entry > 160 mmHg systolic or > 100 mmHg diastolic.
- Current treatment with oral medication for diabetes.
- Pregnant or nursing.
- 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.
- Participant size too large to fit in MR scanner.
- Congestive heart failure with New York Heart Association (NYHA) status >= 2.
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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