Trial Outcomes & Findings for Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED) (NCT NCT00896233)
NCT ID: NCT00896233
Last Updated: 2015-08-25
Results Overview
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.
COMPLETED
PHASE1
10 participants
14 days
2015-08-25
Participant Flow
Part 2 of the study was not conducted; however, in Part 2 of the study, participants would have had a screening visit, followed \~1 month later by one imaging visit. The imaging visit would have consisted of two liver Magnetic Resonance Elastography (MRE) scans.
Participant milestones
| Measure |
Magnetic Resonance Elastography (MRE)
In Part 1 of the study, participants had a screening visit, followed \~1 month later by two imaging visits over \~14 days. Each imaging visit consisted of two liver MRE scans.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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9
|
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Magnetic Resonance Elastography (MRE)
In Part 1 of the study, participants had a screening visit, followed \~1 month later by two imaging visits over \~14 days. Each imaging visit consisted of two liver MRE scans.
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|---|---|
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Overall Study
Claustrophobia during MRI
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1
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Baseline Characteristics
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Magnetic Resonance Elastography (MRE)
n=10 Participants
In Part 1 of the study, participants had a screening visit, followed \~1 month later by two imaging visits over \~14 days. Each imaging visit consisted of two liver MRE scans.
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|---|---|
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Age, Continuous
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45.5 years
STANDARD_DEVIATION 12.9 • n=99 Participants
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Sex: Female, Male
Female
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5 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 14 daysPopulation: Participants analyzed were Completers.
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.
Outcome measures
| Measure |
Reader 1
n=9 Participants
Participant scans evaluated by Reader 1.
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Reader 2
n=9 Participants
Participant scans evaluated by Reader 2.
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|---|---|---|
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Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
MRE Common ROI
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4.54 kPa
Standard Deviation 0.48 • Interval 0.82 to 0.99
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4.64 kPa
Standard Deviation 0.50 • Interval 0.72 to 0.98
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Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
MRE Individual ROI
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5.10 kPa
Standard Deviation 0.44 • Interval 0.78 to 0.98
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5.14 kPa
Standard Deviation 0.41 • Interval 0.75 to 0.98
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PRIMARY outcome
Timeframe: 14 daysPopulation: Participants analyzed were Completers.
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.
Outcome measures
| Measure |
Reader 1
n=9 Participants
Participant scans evaluated by Reader 1.
|
Reader 2
n=9 Participants
Participant scans evaluated by Reader 2.
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|---|---|---|
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Repeated Mean Liver Elastic Stiffness (kPa) Measurements
MRE Common ROI
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3.12 kPa
Standard Deviation 0.26 • Interval 0.8 to 0.99
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3.14 kPa
Standard Deviation 0.31 • Interval 0.78 to 0.99
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Repeated Mean Liver Elastic Stiffness (kPa) Measurements
MRE Individual ROI
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3.08 kPa
Standard Deviation 0.19 • Interval 0.87 to 1.0
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3.15 kPa
Standard Deviation 0.20 • Interval 0.88 to 1.0
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Participants analyzed were Completers.
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.
Outcome measures
| Measure |
Reader 1
n=9 Participants
Participant scans evaluated by Reader 1.
|
Reader 2
n=9 Participants
Participant scans evaluated by Reader 2.
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|---|---|---|
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Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants
MRE Common ROI
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94.41 percent treatment difference
Interval 33.85 to 182.36
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94.66 percent treatment difference
Interval 32.65 to 185.67
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Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants
MRE Individual ROI
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97.02 percent treatment difference
Interval 39.77 to 177.73
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99.31 percent treatment difference
Interval 37.81 to 188.27
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PRIMARY outcome
Timeframe: 14 daysPopulation: Participants analyzed were Completers.
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.
Outcome measures
| Measure |
Reader 1
n=9 Participants
Participant scans evaluated by Reader 1.
|
Reader 2
n=9 Participants
Participant scans evaluated by Reader 2.
|
|---|---|---|
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Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants
MRE Common ROI
|
117.21 percent treatment difference
Interval 33.7 to 252.87
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91.24 percent treatment difference
Interval 32.12 to 176.83
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Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants
MRE Individual ROI
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105.35 percent treatment difference
Interval 38.51 to 204.42
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90.77 percent treatment difference
Interval 34.64 to 170.29
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Adverse Events
Magnetic Resonance Elastography (MRE)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Magnetic Resonance Elastography (MRE)
n=10 participants at risk
In Part 1 of the study, participants had a screening visit, followed \~1 month later by two imaging visits over \~14 days. Each imaging visit consisted of two liver MRE scans.
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|---|---|
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Musculoskeletal and connective tissue disorders
Muscle soreness
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10.0%
1/10 • Number of events 1
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Renal and urinary disorders
Nephrolithiasis
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10.0%
1/10 • Number of events 1
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Investigations
Red blood cells urine positive
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10.0%
1/10 • Number of events 1
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Publications derived from this study should include input from the investigators and SPONSOR personnel.Such input should be reflected in publication authorship.The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER