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

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

Sponsors

Lead Sponsor: University of California, Davis

Source 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 60 people participate in this study at UC Davis. About three-fourths (45) of the participants will be patients who have been diagnosed with NAFLD. The other one-fourth (15) 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.

Overall Status Recruiting
Start Date November 1, 2019
Completion Date December 31, 2022
Primary Completion Date December 31, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
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. FDG PET scan study is for 60 minutes.
Enrollment 60
Condition
Intervention

Intervention Type: Radiation

Intervention Name: Positron Emission Tomography (PET) on EXPLORER

Description: 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.

Other Name: PET Scan

Intervention Type: Diagnostic Test

Intervention Name: Magnetic Resonance Imaging

Description: 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.

Other Name: MRI

Intervention Type: Diagnostic Test

Intervention Name: Echocardiogram and Electrocardiogram

Description: 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.

Other Name: Echo and EKG or ECG

Intervention Type: Diagnostic Test

Intervention Name: Blood test

Description: 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.

Other Name: Lab test

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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 alcholic 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Sandeep Dhaliwal, MD

Phone: 916-734-8696

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: UC Davis Sandeep Dhaliwal, M.D. 916-734-8696 [email protected] Souvik Sarkar, MD., Ph.D Principal Investigator
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, Davis

Investigator Full Name: Souvik Sarkar, MD, PhD

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Arm Group

Label: 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

Label: 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

Acronym EXPLORER
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov