Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:

Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110577
• Other study ID #: 0000-171
• Secondary ID: 171
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: April 8, 2015
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease (NAFLD)
• Prediabetic State

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Mashhood A, Railkar R, Yokoo T, Levin Y, Clark L, Fox-Bosetti S, Middleton MS, Riek J, Kauh E, Dardzinski BJ, Williams D, Sirlin C, Shire NJ. Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging. J Magn Reson Imaging. 2013 Jun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method		28 +/- 7 days from Imaging Visit 1	No
Secondary	ICC for repeated HFF measurements from the 3-point Dixon method		28 +/- 7 days from Imaging Visit 1	No