NCT06176079Completed
Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease
Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 44 (actual)
- First submitted
- 10 Dec 2023
- Start date
- 22 Jul 2020
- Primary completion date
- 28 Aug 2025
- Lead sponsor
- Michael Ohliger, MD PhD
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06176079
What you commit to
- Study type: Observational
- Participants enrolled: 44
- From 22 Jul 2020 to the primary completion date, 28 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with oral medication for diabetes.
Other illness
- 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.
- 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.
- Poorly controlled hypertension, with blood pressure at study entry \> 160 mmHg systolic or \> 100 mmHg diastolic.
- 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.
- Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
Other
- Part 1 (Imaging Optimization): For Cohorts 1/B only:
- Pregnant or nursing.
- Participant size too large to fit in MR scanner.
- Part 2 (Pilot Study): All groups
- Pregnant or nursing.
- Participant size too large to fit in MR scanner.
Who the study is looking for
- 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.
- 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.
- Body mass index \< 25.
- Liver panel normal (aspartate aminotransferase (AST), ALT, alkaline phosphatase, bilirubin).
- HBsAg, HCV antibody, HIV antibody negative.
- Hemoglobin A1c \< 5.7%.
- Estimated glomerular filtration rate (eGFR) \>= 60 mL/min/1.73m\^2
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.