Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER

NCT04165343 | Completed

• 1 other identifier: 1371653
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Multi-Organ Metabolism and Perfusion in Non-Alcoholic Fatty Liver Disease (NAFLD) by Total Body Dynamic PET Scan on EXPLORER

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• Change in myocardial glucose uptake rate (K1) in patient with stage 3-4 liver fibrosis relative to stage 0-2 liver fibrosis

  The primary outcome is to determine heart (myocardial) glucose uptake rate (K1) determined by dynamic FDG PET scan. This will be compared between those with liver fibrosis stage 3-4 with those with lower stage of fibrosis stage 0-2 as determined by magnetic resonance elastography.

  3 years total study period. Fluorodeoxyglucose (FDG) PET scan study is for 60 minutes.

Study Arms (2)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Cohort: Patients with known Non-Alcoholic Fatty Liver Disease (NAFLD) All patients will undergo the following interventions: Positron Emission Tomography (PET) on the EXPLORER scanner Magnetic Resonance Imaging (MRI) Echocardiogram and Electrocardiogram Blood test

Radiation: Positron Emission Tomography (PET) on EXPLORER; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram and Electrocardiogram; Diagnostic Test: Blood test

Healthy Control Subjects

Cohort: Healthy controls All healthy subjects will undergo the following interventions: Positron Emission Tomography (PET) on the EXPLORER scanner Magnetic Resonance Imaging (MRI) Echocardiogram and Electrocardiogram Blood tests

Radiation: Positron Emission Tomography (PET) on EXPLORER; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram and Electrocardiogram; Diagnostic Test: Blood test

Interventions

Positron Emission Tomography (PET) on EXPLORER RADIATION

Positron Emission Tomography (PET): Your blood sugar level will be checked by a finger stick before the PET scan. A small amount of radioactive "tracer" (approximately 0.5 teaspoons) will be injected into a vein in your arm before the imaging test. You will be asked to lay on your back on the EXPLORER scanner platform with both of your arms over the head during the duration of the test. A small amount of blood (1 tablespoon) will be collected after the test. This test will last for up to one (1) hour. This is a research test. Although the results may be available it cannot be used for clinical care. If any incidental findings are noted, it will be reported to you.

Also known as: PET Scan

Healthy Control Subjects; Non-Alcoholic Fatty Liver Disease (NAFLD)

Magnetic Resonance Imaging DIAGNOSTIC_TEST

MRI will be performed that can measure both the liver stiffness or fibrosis by a method called MR elastography (MRE) and the amount of fat deposited in the liver by MR proton density fat fraction (MR-PDFF). You will be asked to lay on your back on the scanner platform with both of your arms over the head during the duration of the test. MRE and MRI-PDFF are Food and Drugs Administration (FDA) approved tests and the results will be available to you. This test will last up to one (1) hour.

Also known as: MRI

Healthy Control Subjects; Non-Alcoholic Fatty Liver Disease (NAFLD)

Echocardiogram and Electrocardiogram DIAGNOSTIC_TEST

You will have baseline echocardiogram images and electrocardiogram (ECG) taken and will be asked to walk on a treadmill, which will increase in elevation and speed every 3 minutes until you can go no longer. This usually takes 9 to 12 minutes. Immediately after exercise, echocardiogram images and ECG will be taken again. The total time you will be in the stress lab including prep time and recovery is about 60 minutes. Wear comfortable or exercise clothing and walking/running shoes. You will be asked to not eat or drink (except for water) for 4 hours prior to the time of your test. Please drink water the day of the test so you are not dehydrated. This is an FDA approved test and the results will be available to you.

Also known as: Echo and EKG or ECG

Healthy Control Subjects; Non-Alcoholic Fatty Liver Disease (NAFLD)

Blood test DIAGNOSTIC_TEST

We will order laboratory blood tests as part of this research study and up to 3 tablespoons of blood will be collected for routine clinical and other laboratory tests relevant to the study. If you are able to become pregnant, you will have a urine pregnancy test before you begin the study.

Also known as: Lab test

Healthy Control Subjects; Non-Alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Individuals of 18 years and older 2. NAFLD patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible

You may qualify if:

• Individuals of 18 years and older
• NAFLD patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible

You may not qualify if:

• History of other liver diseases including viral hepatitis B or C (except those cured \> 3 years), autoimmune hepatitis, cholestatic diseases, significant alcohol use or known alcoholic liver disease
• Participation in a blinded investigational study for NAFLD
• Pregnant women
• Prisoners
• Claustrophobic to MRI and/or PET Scan (EXPLORER)
• Inability to lie or to maintain posture in the scanner for one hour
• Hgb A1c \>9%
• Underwent dynamic FDG PET as part of another study, Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis (IRB 840422) within 12 months

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will order laboratory blood tests as part of this research study and up to 3 tablespoons of blood will be collected for routine clinical and other laboratory tests relevant to the study. An extra of up to 4 teaspoons of blood will be collected for DNA and liver molecules that give information, for future research.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Magnetic Resonance Imaging; Echocardiography; Electrocardiography; Caves; Hematologic Tests

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Clinical Laboratory Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 15, 2019
• Study Start: November 1, 2019
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)