Status:
UNKNOWN
Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease
Lead Sponsor:
Michael Ohliger, MD PhD
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Fatty Liver
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: 1. Optimize scan parameters in order to maximize the signal-to-noise ratio of the HP 13C-pyruvate magnetic resonance imaging (MRI) in the liver. 2. Determine whether the level of ...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06176079
Start Date
July 22 2020
End Date
February 28 2025
Last Update
December 19 2023
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143