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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.
 
ClinicalTrials.gov Identifier: NCT02754037
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : July 12, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: Fluorodeoxyglucose (FDG) positron emission tomography (PET) Other: Magnetic resonance imaging (MRI) Other: Liver magnetic resonance (MR) Perfusion

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis
Actual Study Start Date : April 30, 2016
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Fluorodeoxyglucose (FDG) positron emission tomography (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 University of California 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.
  • 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.
    Other Name: Magnetic resonance proton density fat fraction (MR-PDFF), Magnetic resonance elastography (MRE)
  • Other: Liver magnetic resonance (MR) Perfusion
    The pre-contrast and contrast-enhanced images of the entire liver will be performed using a General Electric (GE) 1.5-T MRI scanner system. Contrast injection will follow the standard clinical I.V. injection of 0.1 mmol/kg of gadoteridol. The temporal resolution will be ~5 seconds, and the whole dynamic scan lasts for about 5 minutes.


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 University of California, 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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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02754037


Contacts
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Contact: Sandeep Dhaliwal, M.D. (916) 734-8696 sandhaliwal@ucdavis.edu
Contact: Souvik Sarkar, M.D., Ph.D. (916) 734-3759 ssarkar@ucdavis.edu

Locations
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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    sandhaliwal@ucdavis.edu   
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: Karen Matsukuma, MD         
Sponsors and Collaborators
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Guobao Wang University of California, Davis
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02754037    
Other Study ID Numbers: 840422
R01DK124803-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
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
Inflammation
Pathologic Processes
Digestive System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action