Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis
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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.
FDG-PET has been utilized in multiple disease processes that have inflammation as the key driver of the disease and has found potentials to be used for imaging of steatohepatitis. Dynamic PET acquires images at multiple time points and enables parametric imaging of FDG kinetics, providing fundamental quantitative information about the kinetic process of glucose metabolism in the liver tissue. Our group at UC Davis has developed a novel kernel-based dynamic (KBD) PET imaging method. The resulting KBD PET method has demonstrated a five-fold gain in signal-to-noise ratio (SNR) when tested on a small group of patients with breast cancer. With this substantial SNR gain, the study group believes the approach has great potential to allow accurate characterization of FDG kinetics in the liver.
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.
PET scan parameters correlated with biopsy findings [ Time Frame: one year ]
PET scan parameters correlated with biopsy findings (NAFLD Activity Score as per NASH-CRN)
Biospecimen Retention: Samples With DNA
Blood plasma/serum will be banked at the UC 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. Sarkar and his study staff will maintain records of the storage location and have access to them.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
Claustrophobic to MRI
Allergic to FDG dye
Patients who are unable to lie in the scanner for one hour