Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study
FLiPP
2 other identifiers
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
April 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 5, 2025
December 1, 2025
10.2 years
April 26, 2016
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PET scan parameters correlated with biopsy findings
PET scan parameters correlated with biopsy findings (NAFLD Activity Score as per NASH-CRN)
one year
Interventions
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.
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.
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.
Eligibility Criteria
The study population includes those who are scheduled to have bariatric surgery (weight loss surgery) or have had a liver biopsy within the past six months with a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). These
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis Medical Center
Sacramento, California, 95817, United States
Related Publications (1)
Sarkar S, Chen S, Spencer B, Situ X, Afkarian M, Matsukuma K, Corwin MT, Wang G. Non-Alcoholic Steatohepatitis Severity Associates with FGF21 Level and Kidney Glucose Uptake. Metab Syndr Relat Disord. 2021 Nov;19(9):491-497. doi: 10.1089/met.2021.0055. Epub 2021 Aug 26.
PMID: 34448598DERIVED
Related Links
Biospecimen
Blood plasma/serum will be banked at the University of California, Davis GI Biobank for future liver-related study use in -80°C freezer. Samples will be used for liver related studies. Potential future analyses of plasma samples could include fatty liver metabolomics analyses. All future Sample specimens will be stored for as long as they are viable (for up to 20 years). Dr. Medici and her study staff will maintain records of the storage location and have access to them.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guobao Wang
University of California, Davis
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
April 28, 2016
Study Start
April 30, 2016
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 5, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared