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Active, Not Recruiting

NCT Number: NCT02754037

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

The goal of this study is to evaluate non-invasive imaging techniques for determining liver steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue scarring).In addition, the study group will be using other test measures including personal demographics, laboratory blood test results, and imaging measurements to determine the severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis), inflammation, and fibrosis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis (NASH)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

The study group proposes to evaluate the role of fluorodeoxyglucose (FDG) positron emission tomography (PET) in the determination of steatohepatitis and in combination with MRI for detection, differentiation and quantitation of liver steatosis, steatohepatitis and fibrosis in correlation to liver biopsy. Patient enrolled in this will already have had their liver biopsy or will be undergoing liver biopsy as a part of their clinical care as determined by their provider and will not be getting biopsies solely to be enrolled in the study. Current treatment options for patients that liver biopsy is being performed are limited to lifestyle changes and vitamin E for patients without diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >18 years age
  • Patients who had or will have a liver biopsy as standard of care for fatty liver disease and have risk factors for NASH. Liver biopsy needs to be within 6 months of planned imaging.
  • Patients undergoing bariatric surgery and will have a liver biopsy as standard of care.
  • Ability to provide informed consent.

Exclusion criteria

  • History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
  • Pregnant women
  • Prisoners
  • Claustrophobic to MRI
  • Allergic to FDG dye
  • Patients who are unable to lie in the scanner for one hour

Treatment and study plan

Fluorodeoxyglucose (FDG) positron emission tomography (PET)

Radiation

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.

magnetic resonance imaging (MRI)

Other

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.

Other names: Magnetic resonance proton density fat fraction (MR-PDFF), Magnetic resonance elastography (MRE)

PET Explorer

Radiation

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.

Primary outcomes

  1. PET scan parameters correlated with biopsy findings

    Time frame: one year

    PET scan parameters correlated with biopsy findings (NAFLD Activity Score as per NASH-CRN)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

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

Registry information

Acronym: FLiPP

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2016
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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