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

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896233
• Other study ID #: 0000-132
• Secondary ID: 2009_588
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: August 11, 2015
• Start date: August 2009
• Est. completion date: January 2010

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatitis C Virus
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Procedure:
• MRE
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No