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Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

NCT03674528 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2024-09-19

No results posted yet for this study

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

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Non-alcoholic Steatohepatitis

Interventions

OTHER

Magnetic Resonance Elastography (MRE)

The MRE scan will several breath holds and will take approximately 30 minutes to complete.

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • GE Healthcare

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Siemens Medical Solutions

    collaborator INDUSTRY

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Scott Reeder, MD, PhD · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2024-06-11
Completion
2024-06-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674528 on ClinicalTrials.gov