- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674528
Technical Validation of MR Biomarkers of Obesity-Associated NAFLD (NAFLD)
Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92093
- University of California, San Diego
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Wisconsin
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Madison, Wisconsin, United States, 53704
- University of Wisconsin, Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Control Group
Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session.
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The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Names:
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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.
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The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Names:
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:
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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
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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.
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Up to 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Reeder, MD, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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