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MRE · 1 trial · 2 indications
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...
MRE is an investigational diagnostic approach being studied for liver fibrosis, including in patients with hepatitis C virus. It is in Phase 1 clinical development and is not yet approved. A completed trial assessed its use in 10 participants with liver fibrosis and hepatitis C.
MRE is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational approach for liver fibrosis.
MRE is in Phase 1 clinical development. It is an investigational approach and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
MRE has one completed clinical trial, NCT00896233, titled "Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)." This Phase 1 study enrolled 10 participants with liver fibrosis and hepatitis C virus.
MRE is not approved by the FDA. It is an investigational approach in Phase 1 clinical development for liver fibrosis. The completed trial was an uncontrolled study, and no active trials are currently listed.