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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Liver Diseases
Non-alcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver

Clinical Trial Details

NCT number	NCT05081427
Study type	Observational
Source	Mayo Clinic
Contact
Status	Completed
Phase
Start date	November 15, 2021
Completion date	June 30, 2022

View Details

See also
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