NCT05081427

Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE) Study 1.2

Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study: Study 1.2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, observational, single-center, short-term cross-sectional study to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers.

Detailed description

NIMBLE is a comprehensive, five-year collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). The purpose of this study is to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers. The imaging biomarkers will cover an array of methods that could be applicable to non-alcoholic fatty liver disease (NAFLD), including liver fat, liver stiffness, corrected T1 relaxation time and body composition assessments. The data collected will be used to inform a decision of which of these biomarkers has sufficient precision to be advanced to NIMBLE Stage 2.

Conditions

• Nonalcoholic Fatty Liver

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-10-18
• Last updated: 2022-11-29

Locations

1 site across 1 country: United States