Non-alcoholic Fatty Liver Disease (NAFLD)
Conditions
Keywords
MRI, Hepatic Steatosis Study
Brief summary
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is able to travel to MRI centers * All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit * Patient is male or female and at least 18 years of age * At least 5 patients have type 2 diabetes mellitus or pre-diabetes
Exclusion criteria
* Female patient is pregnant or has a positive pregnancy test at screening; * Patient has known liver disease other than fatty liver * Patient has a history of neoplastic disease * Patient is HIV positive * Patient has known claustrophobia or other contraindication to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method | 28 +/- 7 days from Imaging Visit 1 |
Secondary
| Measure | Time frame |
|---|---|
| ICC for repeated HFF measurements from the 3-point Dixon method | 28 +/- 7 days from Imaging Visit 1 |
Outcome results
None listed