Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study

Active, not recruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Non-alcoholic Fatty Liver Disease (NAFLD)Non-alcoholic Steatohepatitis (NASH)
Interventions
RADIATION

Fluorodeoxyglucose (FDG) positron emission tomography (PET)

This imaging method uses radiotracers for functional analysis of liver inflammation. It does involve placement of an intravenous catheter and a radiotracer. One blood sample (10cc) will be drawn after PET scan using a butterfly method with the time recorded. The blood sample will be centrifuged in the Main Hospital to get the plasma and a well counter will be used to calculate the radioactivity in the plasma as per established protocol. Potential risks from an intravenous catheter insertion and blood draw include pain, minimal blood loss and local erythema. Radiotracer exposure from FDG-PET is minimal and has been well-characterized. Radiation Use Committee approval has been obtained for FDG-PET use.

OTHER

Magnetic resonance imaging (MRI)

Novel non-invasive MRI based tools to assess liver fat and fibrosis. Potential risks include a sensation of claustrophobia. No contrast dye is used and thus no risk of contrast allergy. Inflammation of the liver may be assessed by MRI software after processing of images and does not require additional patient involvement or change in MRI protocol.

RADIATION

PET Explorer

Similar to the regular PET-Scan, this imaging method uses radiotracers to scan multiple organs of the body. It does involve placement of an intravenous catheter and a radiotracer. One blood sample (10cc) will be drawn after PET scan using a butterfly method with the time recorded. The blood sample will be centrifuged in the Main Hospital to get the plasma and a well counter will be used to calculate the radioactivity in the plasma as per established protocol. Potential risks from an intravenous catheter insertion and blood draw include pain, minimal blood loss and local erythema. Radiotracer exposure from FDG-PET is minimal and has been well-characterized. Radiation Use Committee approval has been obtained for FDG-PET use.

Trial Locations (1)

95817

University of California Davis Medical Center, Sacramento

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of California, Davis

OTHER