Technical Validation of MR Biomarkers of Obesity-Associated NAFLD



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:May 4, 2018
End Date:May 1, 2023
Contact:Gemma Gliori, MS
Email:radstudy@uwhealth.org
Phone:608-262-7269

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Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease

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.

Inclusion Criteria:

- 18 years of age or older

- BMI greater/equal to 35 kilograms per meter squared

- Phase 2 subjects must be eligible for weight loss surgery and willing to undergo a
research biopsy procedure

Exclusion Criteria:

- Unable to undergo and MRI scan

- Women that are pregnant or breastfeeding

- Phase 2 subjects must not have known liver disease, engage in excessive alcohol
consumption, or take medication that is hepatotoxic
We found this trial at
1
site
Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Scott Reeder, MD, PhD
Phone: 608-262-7269
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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