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

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ClinicalTrials.gov Identifier: NCT04165343
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Souvik Sarkar, MD, PhD, 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

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease NASH - Nonalcoholic Steatohepatitis Radiation: Positron Emission Tomography (PET) on EXPLORER Diagnostic Test: Magnetic Resonance Imaging Diagnostic Test: Echocardiogram and Electrocardiogram Diagnostic Test: Blood test

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
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
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

Diagnostic Test: Magnetic Resonance Imaging
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

Diagnostic Test: Echocardiogram and Electrocardiogram
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

Diagnostic Test: Blood 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.
Other Name: Lab 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
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

Diagnostic Test: Magnetic Resonance Imaging
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

Diagnostic Test: Echocardiogram and Electrocardiogram
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

Diagnostic Test: Blood 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.
Other Name: Lab test




Primary Outcome Measures :
  1. Change in myocardial glucose uptake rate (K1) in patient with stage 3-4 liver fibrosis relative to stage 0-2 liver fibrosis [ Time Frame: 3 years total study period. 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.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165343


Contacts
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Contact: Sandeep Dhaliwal, MD 916-734-8696 sandhaliwal@ucdavis.edu
Contact: Joseph Zepeda, BS 916-734-8985 jlzepeda@ucdavis.edu

Locations
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United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Sandeep Dhaliwal, M.D.    916-734-8696    sandhaliwal@ucdavis.edu   
Contact: Joseph Zepeda, B.S.    916-734-8985    jlzepeda@ucdavis.edu   
Principal Investigator: Souvik Sarkar, MD., Ph.D         
Sponsors and Collaborators
University of California, Davis

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Responsible Party: Souvik Sarkar, MD, PhD, Assistant Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT04165343     History of Changes
Other Study ID Numbers: 1371653
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases