Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Conditions
Keywords
MRI, MRE, Liver Disease, Liver Fibrosis
Brief summary
The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance
Detailed description
The long-term objective of this research is to improve the health of the millions of Americans with or at risk for NAFLD, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the United States. To achieve this objective, an advanced MR-based imaging method will be used to measure liver stiffness which is an early sign of disease. This technique has been previously developed and validated and ready to be used for further research. This current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (MRE) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (NASH), the histologically more aggressive subset of NAFLD. Per Amendment approved 4/8/22: MRE exams will be conducted using a PDFF Pocket Phantom purchased by the UCSD from Calimetrix. This phantom consists of vials with known fat fraction which are captured when taking images of the liver. The known fat fractions provide an independent reference and are used for quality assurance purposes.
Interventions
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
DIAGNOSTIC_TESTLiver biopsy
Subjects undergoing WLS will be asked to allow for liver biopsy samples to be collected during their surgical procedure. The collection of these samples will take approximately 5 minutes to complete.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
GE Healthcare
Pfizer
Siemens Medical Solutions
National Center for Advancing Translational Sciences (NCATS)
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Phase 1 and 2 participants) * Age of at least 18 years * Severely obese (BMI ≥ 35 kg/m2) patient Inclusion Criteria (Phase 2 participants only) * Cleared for weight-loss surgery * Willing and able to complete all safety and follow-up procedures * Willing to allow for the banking of biological samples
Exclusion criteria
(Phase 1 and 2 participants) * Contraindications to MRI * Girth or weight that exceeds scanner capacity * Women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimization of MRE for 2 dimensional and 3 dimensional methods | Up to 24 months | Optimize MRE wave-field generation in this subject population to maximize the area of invertible shear waves in the liver into interpretable shear stiffness maps. |
Countries
United States
Outcome results
None listed