NCT00896233 - Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED) | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

10

Conditions

Liver Fibrosis Hepatitis C Virus

Interventions

MREPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.