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

NCT04165343 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2023-09-01

No results posted yet for this study

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)

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-05-11
Completion
2023-05-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165343 on ClinicalTrials.gov