Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:April 2016
End Date:December 10, 2027
Contact:Sandeep Dhaliwal
Email:sandhaliwal@ucdavis.edu
Phone:(916) 734-8696

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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.

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.

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
We found this trial at
1
site
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Souvik Sarkar, M.D., Ph.D.
Phone: 916-734-8696
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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mi
from
Sacramento, CA
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