Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

NCT03674528 | Completed DMC FDA Device

• 6 other identifiers: 2018-02442R01DK088925-06A1A539300SMPH/RADIOLOGY/RADIOLOGYProtocol Version 3/8/20225UL1TR002373-04
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

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

Conditions

Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Keywords

MRI; MRE; Liver Disease; Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Optimization of MRE for 2 dimensional and 3 dimensional methods

  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

Study Arms (2)

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)

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); Diagnostic Test: Liver biopsy

Interventions

Magnetic Resonance Elastography (MRE) OTHER

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

Also known as: MRI

Control Group; Patient Group

Liver biopsy DIAGNOSTIC_TEST

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.

Also known as: Intraoperative Biopsy

Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age of at least 18 years
• Severely obese (BMI ≥ 35 kg/m2) patient
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• GE Healthcare: collaborator
• Pfizer: collaborator
• Siemens Medical Solutions: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Reeder, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: September 17, 2018
• Study Start: May 4, 2018
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (2)