Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点