Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis

Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis

Sponsors

Lead Sponsor: University of California, Davis

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source 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.

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.

Overall Status Recruiting
Start Date 2016-04-30
Completion Date 2024-06-30
Primary Completion Date 2024-06-30
Study Type Observational
Primary Outcome
Measure Time Frame
PET scan parameters correlated with biopsy findings one year
Enrollment 120
Condition
Intervention

Intervention Type: Radiation

Intervention Name: Fluorodeoxyglucose (FDG) positron emission tomography (PET)

Description: 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.

Intervention Type: Other

Intervention Name: Magnetic resonance imaging (MRI)

Description: 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)

Intervention Type: Other

Intervention Name: Liver magnetic resonance (MR) Perfusion

Description: 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.

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Guobao Wang Principal Investigator University of California, Davis
Overall Contact

Last Name: Sandeep Dhaliwal, M.D.

Phone: (916) 734-8696

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of California Davis Medical Center Sandeep Dhaliwal 916-734-8696 [email protected] Souvik Sarkar, M.D., Ph.D. Principal Investigator Guobao Wang, PhD Sub-Investigator Michael Corwin, M.D. Sub-Investigator Ramsey Badawi, PhD Sub-Investigator Karen Matsukuma, MD Sub-Investigator
Location Countries

United States

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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