Clinical trial NCT02754037: Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study
Official title: Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Non-alcoholic Steatohepatitis (NASH)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients \>18 years age
2. 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.
3. Patients undergoing bariatric surgery and will have a liver biopsy as standard of care.
4. Ability to provide informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: PET scan parameters correlated with biopsy findings
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Guobao Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.