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Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02754037
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 21, 2019
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment
Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH) Radiation: FDG-PET Radiation: MRI-PDFF

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis
Study Start Date : April 2016
Estimated Primary Completion Date : December 10, 2027
Estimated Study Completion Date : December 10, 2027

Intervention Details:
  • Radiation: FDG-PET
    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.
  • Radiation: MRI-PDFF
    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.
    Other Name: MRE

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02754037

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Contact: Sandeep Dhaliwal (916) 734-8696
Contact: Souvik Sarkar, M.D., Ph.D. (916) 734-3759

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United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Sandeep Dhaliwal    916-734-8696   
Principal Investigator: Souvik Sarkar, M.D., Ph.D.         
Sub-Investigator: Guobao Wang, PhD         
Sub-Investigator: Michael Corwin, M.D.         
Sub-Investigator: Ramsey Badawi, PhD         
Sub-Investigator: Kristin Olson, MD         
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis Identifier: NCT02754037     History of Changes
Other Study ID Numbers: 840422
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Digestive System Diseases