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

Study Overview
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Brief Summary
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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.

Official Title
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Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients

Conditions
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Liver Fibrosis, Hepatitis C Virus

Intervention / Treatment
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* Procedure: MRE


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRE<br> | Procedure: MRE<br>* Part 1: Participants will have a screening visit, followed  1 month later by two imaging visits over  14 days. Each imaging visit will consist of two liver MRE scans. Part 2: Participants will have a screening visit, followed  1 month later by one imaging visit. The imaging visit will consist of two liver MRE scans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements | 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. | 14 days | 
| Repeated Mean Liver Elastic Stiffness (kPa) Measurements | 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. | 14 days | 
| Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants | 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. | 14 days | 
| Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus