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

Completed

• Conditions: Nonalcoholic Steatohepatitis (NASH); Non-Alcoholic Fatty Liver Disease (NAFLD)
• Interventions: Radiation: Positron Emission Tomography (PET) on EXPLORER; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram and Electrocardiogram; Diagnostic Test: Blood test

• Registration Number: NCT04165343
• Lead Sponsor: University of California, Davis

Brief Summary

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

Detailed Description

You are invited to participate in a research study that seeks to understand the effect of non-alcoholic fatty liver disease (NAFLD) on organs other than the liver. One of the most common organs affected in patients with NAFLD is the heart. We expect to have about 88 people participate in this study at University of California (UC), Davis. About three-fourths (66) of the participants will be patients who have been diagnosed with NAFLD. The other one-fourth (22) will be healthy individuals with no known liver disease. These healthy subjects will allow researchers to compare healthy organs or body functions with those of persons with NAFLD. The healthy participants are called the "Healthy Control" group. All participants will undergo the same testing.

If you agree to participate in this study, researchers will first interview you and review your medical records in order to document your medical (clinical) history. You will also have a physical examination by a doctor and a blood test. You will then undergo a series of imaging tests to determine the status of your liver, heart and other internal organs.

All participants will have a PET/CT Scan (Positron Emission Tomography), and an MRI (Magnetic Resonance Imaging). All participants will also have an Electrocardiogram and an Echocardiogram. All Electrocardiogram tests are the same, but there are two types of Echocardiogram tests. One is like a standard ultra-sound imaging of your heart. The other is a "Stress Cardio" that will require you to increase your heart rate on a treadmill before the ultra-sound test. Your study doctor will determine which test you have.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Participation in a blinded investigational study for NAFLD
3. Pregnant women
4. Prisoners
5. Claustrophobic to MRI and/or PET Scan (EXPLORER)
6. Inability to lie or to maintain posture in the scanner for one hour
7. Hgb A1c >9%
8. Underwent dynamic FDG PET as part of another study, Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis (IRB 840422) within 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Alcoholic Fatty Liver Disease (NAFLD)	Magnetic Resonance Imaging	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
Non-Alcoholic Fatty Liver Disease (NAFLD)	Positron Emission Tomography (PET) on EXPLORER	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
Healthy Control Subjects	Positron Emission Tomography (PET) on EXPLORER	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
Non-Alcoholic Fatty Liver Disease (NAFLD)	Echocardiogram and Electrocardiogram	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
Non-Alcoholic Fatty Liver Disease (NAFLD)	Blood test	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
Healthy Control Subjects	Magnetic Resonance Imaging	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
Healthy Control Subjects	Blood test	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
Healthy Control Subjects	Echocardiogram and Electrocardiogram	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

Primary Outcome Measures

Name	Time	Method
Change in myocardial glucose uptake rate (K1) in patient with stage 3-4 liver fibrosis relative to stage 0-2 liver fibrosis	3 years total study period. Fluorodeoxyglucose (FDG) PET scan study is for 60 minutes.	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.

Trial Locations

Locations (1)

UC Davis; 🇺🇸 Sacramento, California, United States