Summary

for people ages 18 years and up (full criteria)
at Sacramento, California
study started
estimated completion
Souvik Sarkar, M.D., Ph.D.

Description

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.

Details

The study group proposes to evaluate the role of KBD FDG-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.

Keywords

Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH) Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Inflammation FDG-PET MRI-PDFF

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Location

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

  • Souvik Sarkar, M.D., Ph.D.
    Assistant Professor, Gastroenterology and Hepatology. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT02754037
Study Type
Observational
Last Updated