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

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

— FLiPP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02754037
• Other study ID #: 840422
• Secondary ID: R01DK124803-01A1
• Status: Active, not recruiting
• Start date: April 30, 2016
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease (NAFLD)
• Non-alcoholic Steatohepatitis (NASH)

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET scan parameters correlated with biopsy findings	PET scan parameters correlated with biopsy findings (NAFLD Activity Score as per NASH-CRN)	one year

External Links

•   Learn more or sign up for the study here!