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

Description

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.

Conditions

Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis, NAFLD, NASH

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non-Alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Able and willing to sign informed consent.
  • 2. Age \>= 18 years old at the time of study entry.
  • * 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.
  • 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
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Michael Ohliger, MD PhD,

Michael Ohliger, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-02-28