Hyperpolarized MRI for assessing fatty liver disease

Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease

This study is testing a new type of MRI using a special injection to see if it can help doctors better understand and measure changes in the livers of people with fatty liver disease.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06176079 on ClinicalTrials.gov

What this trial studies

This pilot study aims to optimize magnetic resonance imaging (MRI) techniques using hyperpolarized 13C pyruvate to non-invasively evaluate metabolic changes in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The study will involve healthy volunteers and patients with fatty liver disease to compare lactate production levels and improve imaging parameters. Participants will receive hyperpolarized 13C injections, and the study will also explore the safety profile of these injections and develop data analysis methods for quantifying the imaging results.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed non-alcoholic fatty liver disease or non-alcoholic steatohepatitis.

Not a fit: Patients with significant alcohol consumption or other liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method for early detection and monitoring of fatty liver disease progression.

How similar studies have performed: While the use of hyperpolarized MRI is a novel approach, similar imaging techniques have shown promise in other metabolic conditions.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Michael Ohliger, MD — University of California, San Francisco
• Study coordinator: Louise Magat

Conditions Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Non Alcoholic Steatohepatitis; NAFLD; NASH