Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00896233 | Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED) | PHASE1 | COMPLETED | 10 | — | — | Aug 1, 2009 | Jan 1, 2010 | Aug 25, 2015 | - | — |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| MRE | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
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...