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

University of California (UC) Davis

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04165343

1371653

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

Non-Alcoholic Fatty Liver Disease (NAFLD)

Description:

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

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Magnetic Resonance Imaging

Diagnostic Test: Echocardiogram and Electrocardiogram

Radiation: Positron Emission Tomography (PET) on EXPLORER

Healthy Control Subjects

Description:

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

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Magnetic Resonance Imaging

Diagnostic Test: Echocardiogram and Electrocardiogram

Radiation: Positron Emission Tomography (PET) on EXPLORER