Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)

Phase 1

Completed

• Conditions: Liver Fibrosis; Hepatitis C Virus
• Interventions: Procedure: MRE

• Registration Number: NCT00896233
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an alternative to liver biopsy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Study Start: 2009-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-01-18
• Results First Submitted QC: 2011-08-17
• Results First Posted: 2011-09-22
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Male or female and at least 18 years of age
• Generally good health
• Willing to fast for 8 hours prior to each study visit

Hepatitis C Virus (HCV) Inclusion Criteria:

• Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;

For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)

• Never been treated for HCV

Healthy Participant Inclusion Criteria:

• Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening

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Exclusion Criteria

• History of stroke, seizures, or neurological disorders
• Consumption of excessive amounts of alcohol
• Use of products containing nicotine
• Unable to hold a breath for 20 seconds
• Claustrophobia
• Use of illicit drugs or history of drug or alcohol abuse

HCV-Positive Exclusion Criteria:

• Evidence or history of chronic hepatitis not caused by HCV
• HIV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRE	MRE	-

Primary Outcome Measures

Name	Time	Method
Repeated Mean Liver Elastic Stiffness (kPa) Measurements	14 days	Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements	14 days	Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants	14 days	Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.
Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants	14 days	Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.