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

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ClinicalTrials.gov Identifier: NCT03674528
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Other: Magnetic Resonance Elastography (MRE) Diagnostic Test: Liver biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2023


Arm Intervention/treatment
Active Comparator: Control Group
Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session.
Other: Magnetic Resonance Elastography (MRE)
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Name: MRI

Experimental: 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.
Other: Magnetic Resonance Elastography (MRE)
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Other Name: MRI

Diagnostic Test: Liver biopsy
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 Name: Intraoperative Biopsy




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674528


Contacts
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Contact: Gemma Gliori, MS 608-262-7269 radstudy@uwhealth.org
Contact: Suzanne Hanson, BS 608-263-7421 radstudy@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53704
Contact: Gemma Gliori, MS    608-262-7269    radstudy@uwhealth.org   
Contact: Suzanne Hanson, BS    608-263-7421    radstudy@uwhealth.org   
Principal Investigator: Scott Reeder, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Scott Reeder, MD, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03674528     History of Changes
Other Study ID Numbers: 2018-0244
2R01DK088925-06A1 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Wisconsin, Madison:
MRI
MRE
Liver Disease
Liver Fibrosis
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Liver Extracts
Hematinics