Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

Active, not recruiting

• Conditions: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Magnetic Resonance Elastography (MRE); Diagnostic Test: Liver biopsy

• Registration Number: NCT03674528
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2018-05-04
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Magnetic Resonance Elastography (MRE)	Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session.
Patient Group	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.
Patient Group	Liver biopsy	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

University of Wisconsin, Madison; 🇺🇸 Madison, Wisconsin, United States