Technical Validation of MR Biomarkers of Obesity-Associated NAFLD (NAFLD)

December 18, 2023 updated by: University of Wisconsin, Madison

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

Study Overview

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 Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • University of Wisconsin, Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Exclusion Criteria (Phase 2 participants only)

  • Known liver malignancies
  • Regular & excessive alcohol consumption within 2 years prior to recruitment
  • Use of steatogenic or hepatotoxic drugs
  • Clinical or laboratory evidence of liver disease other than Nonalcoholic fatty liver disease (NAFLD)/ Nonalcoholic steatohepatitis (NASH) (e.g. HCV Ab, HBV Ab, ceruloplasmin)
  • The subject has increased bleeding risk (i.e., decreased platelets, von Willebrand disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session.
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Names:
  • MRI
Patient Group
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.
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Names:
  • 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.
Other Names:
  • Intraoperative Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimization of MRE for 2 dimensional and 3 dimensional methods
Time Frame: 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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-0244
  • A539300 (Other Identifier: UW- Madison)
  • SMPH/RADIOLOGY/RADIOLOGY (Other Identifier: UW Madison)
  • 2R01DK088925-06A1 (U.S. NIH Grant/Contract)
  • Protocol Version 3/8/2022 (Other Identifier: UW Madison)
  • 5UL1TR002373-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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