A Phase 1 interventional study of MRE in Liver Fibrosis and Hepatitis C Virus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-25.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Diagnostic
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.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's enrollment of 10 is below the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hepatitis C Virus (HCV) Inclusion Criteria:
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)
Healthy Participant Inclusion Criteria:
Exclusion Criteria:
HCV-Positive Exclusion Criteria:
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.
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
| Milestone | Magnetic Resonance Elastography (MRE) |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Claustrophobia during mri | 1 |
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.
| kPa | Reader 1 | Reader 2 |
|---|---|---|
| MRE Common ROI | 4.54 ± 0.48 | 4.64 ± 0.50 |
| MRE Individual ROI | 5.10 ± 0.44 | 5.14 ± 0.41 |
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.
| kPa | Reader 1 | Reader 2 |
|---|---|---|
| MRE Common ROI | 3.12 ± 0.26 | 3.14 ± 0.31 |
| MRE Individual ROI | 3.08 ± 0.19 | 3.15 ± 0.20 |
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 treatment difference | Reader 1 | Reader 2 |
|---|---|---|
| MRE Common ROI | 94.41 (33.85 to 182.36) | 94.66 (32.65 to 185.67) |
| MRE Individual ROI | 97.02 (39.77 to 177.73) | 99.31 (37.81 to 188.27) |
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 treatment difference | Reader 1 | Reader 2 |
|---|---|---|
| MRE Common ROI | 117.21 (33.70 to 252.87) | 91.24 (32.12 to 176.83) |
| MRE Individual ROI | 105.35 (38.51 to 204.42) | 90.77 (34.64 to 170.29) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnetic Resonance Elastography (MRE) | — | 0/10 (0%) | 1/10 (10%) |
| Event | Magnetic Resonance Elastography (MRE) |
|---|---|
| Muscle sorenessMusculoskeletal and connective tissue disorders | 1/10 |
| NephrolithiasisRenal and urinary disorders | 1/10 |
| Red blood cells urine positiveInvestigations | 1/10 |
| Age, Continuous(years) | Magnetic Resonance Elastography (MRE) |
|---|---|
| Mean | 45.5 ± 12.9 |
| Sex: Female, Male(Participants) | Magnetic Resonance Elastography (MRE) |
|---|---|
| Female | 5 |
| Male | 5 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.