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

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.

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Key information

Conditions

Liver Fibrosis Blood-Borne Infections Communicable Diseases Digestive System Diseases Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Virus Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRE

Procedure

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.

Primary outcomes

Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements

Time frame: 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.
Repeated Mean Liver Elastic Stiffness (kPa) Measurements

Time frame: 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.
Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 11, 2009
Registry last updated: Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed