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.
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 Type
OBSERVATIONAL
Enrollment
17
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Reproducibility of liver stiffness
Repeatability liver stiffness in kilopascals (kPa)
Time frame: Within 7 days
Reproducibility of liver fat content
Repeatability of liver proton density fat fraction (PDFF) in %
Time frame: Within 7 days
Reproducibility of visceral adipose tissue volume
Repeatability of visceral adipose tissue volume measured in mL
Time frame: Within 7 days
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