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

Launched by MICHAEL OHLIGER, MD PHD · Dec 10, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called hyperpolarized (HP) 13C magnetic resonance imaging (MRI) to better understand changes in the liver caused by non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The goal is to see how this advanced imaging can help doctors analyze the metabolic changes in patients with these conditions compared to healthy individuals. By participating, you may help researchers learn more about how these diseases progress and how they can be diagnosed without invasive procedures.

To be eligible for the study, you need to be at least 18 years old and able to provide informed consent. There are different groups for participants: one for those diagnosed with NAFLD, another for those with NASH, and a third for healthy volunteers. Key requirements include having no significant liver disease or diabetes, and not being pregnant or nursing. If you choose to take part, you can expect to undergo a non-invasive MRI scan, which will help researchers gather important information about liver health. Your participation could contribute to advancements in the understanding and treatment of fatty liver diseases.

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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.