An observational study in Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, sponsored by University of Wisconsin, Madison. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Wisconsin, Madison · Observational
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
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.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 152 is close to the median of 150 across 359 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase 1 participants will be healthy adults with a BMI of greater/equal to 35 kilograms per meter squared.
Phase 2 participants must be eligible for weight loss surgery and willing to undergo a liver biopsy procedure.
Inclusion Criteria (Phase 1 and 2 participants)
Inclusion Criteria (Phase 2 participants only)
Exclusion Criteria (Phase 1 and 2 participants)
Exclusion Criteria (Phase 2 participants only)
Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session.
Other: Magnetic Resonance Elastography (MRE)
Adults that are candidates for weight loss surgery will be asked to participate in four study visits that include MRE imaging and 1 - 2 liver biopsy procedures.
Other: Magnetic Resonance Elastography (MRE) · Diagnostic Test: Liver biopsy
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Also known as: MRI
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.
Also known as: Intraoperative Biopsy
Optimization of MRE for 2 dimensional and 3 dimensional methods
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.
Time frame: Up to 24 months
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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