Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease
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 | Recruiting |
Enrollment | 80 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Michael Ohliger, MD PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal coil placement (Part 1) | Establishing suitable radiofrequency (RF) coils for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol. | 1 day | |
Primary | Optimal pulse sequences (Part 1) | Establishing the pulse sequences for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol. | 1 day | |
Primary | Optimal respiratory parameter (Part 1) | Establishing the magnitude of respiratory motion for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol. | 1 day | |
Primary | Mean lactate/pyruvate conversion rate (kPL) (Part 1, Cohort B) | Mean lactate-to-pyruvate conversion will be calculated with 95% confidence intervals. | 1 day | |
Primary | Signal-to-noise ratio (SNR) (Part 1, Cohort B) | SNR will be calculated.. | 1 day | |
Primary | Mean lactate-to-pyruvate ratio (Part 2) | The mean lactate-to-pyruvate ratio will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers. | 1 day | |
Primary | Mean kPL(Part 2) | The mean kPL will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers. | 1 day |
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