This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED) (NCT00896233), a non-randomized phase 1 study. The primary outcome is Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00896233 |
| Phase | Phase 1 |
| Condition | Liver Fibrosis, Hepatitis C Virus |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study included healthy volunteers and hepatitis C virus (HCV)-infected patients with fibrosis. The registry record says the participants analyzed were completers, but does not report how many completers there were or how enrollment was divided between these groups.
Intervention
The procedure was magnetic resonance elastography (MRE), a method used in this study to obtain liver stiffness measurements. The record describes repeated readings and two approaches to defining the region of interest in the liver.
Comparator
This was a single-group, nonrandomized study with no masking. It did not include a like-for-like control arm. The comparison described for the primary outcome is between two ways of selecting the liver region of interest, not between randomized treatment groups.
Primary question
How repeatable are maximum liver elastic stiffness measurements obtained by MRE over 14 days, and how do measurements based on an individual region of interest compare with those based on a common region of interest? The registry record describes the measurement procedures but does not report the numerical results needed to answer how large the observed within-participant variation was.
The study was intended to assess repeatability in healthy volunteers and HCV-infected patients with fibrosis, and to lay groundwork for evaluating MRE as an alternative to liver biopsy. Repeatability concerns whether repeated measurements under the study conditions give similar values. It is distinct from whether a measurement correctly identifies fibrosis or can replace a biopsy. Those broader questions are not answered by the study objective alone.
3. Trial Design
This completed Phase 1 study evaluated MRE measurements in a single group. Its allocation is listed as nonrandomized, masking as none, and model as single group. The registry record lists enrollment of 10 and an MRE procedure; it does not describe a separate control group. The enrolled population was intended to include healthy volunteers and HCV-infected patients with fibrosis, but the number in each group and the number analyzed in each group are not reported in the registry record.
The study began in 2009-08, and its primary completion is listed as 2010-01. The primary outcome timeframe is 14 days. The outcome description says a reader evaluated 4 sections of the liver at 4 different time points. At each time point, the reader identified a region of interest in the registered elastograms. The analysis compared measurements using an Individual ROI approach and a Common ROI approach.
These design features make the study a measurement-repeatability investigation rather than a randomized comparison of clinical interventions. Repeated readings can help characterize how much measurements vary under the conditions used, but the design does not by itself establish diagnostic accuracy, agreement with biopsy, or performance in populations outside those enrolled. Details such as the recruitment process, the schedule of individual visits, the technical acquisition protocol, and the rationale for the enrollment target are not reported in the registry record.
The registry record identifies participants analyzed as completers. It does not report the number who completed the study, whether all enrolled participants contributed to each analysis, or how participant flow was handled. Although the record lists 4 outcome measures and 8 analyses, their detailed numerical findings are not reported in the information available for this interpretation.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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.
Overall Study
| Stage | Magnetic Resonance Elastography (MRE) |
|---|---|
| STARTED | 10 |
| COMPLETED | 9 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Magnetic Resonance Elastography (MRE) |
|---|---|
| Claustrophobia during MRI | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants analyzed were Completers.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Magnetic Resonance Elastography (MRE) |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 45.5 (SD 12.9) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements, measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | kPa |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is repeated maximum liver elastic stiffness measured in kilopascals (kPa). Stiffness is the quantitative measurement of interest: the study assesses whether repeated MRE readings of the liver yield similar values over the stated 14-day timeframe. In general, a repeatable measurement has relatively little variation when the same underlying feature is measured repeatedly under comparable conditions. Repeatability is an important measurement property, but it is not the same as diagnostic validity.
The outcome description says a reader evaluated 4 liver sections at 4 different time points and derived a region of interest (ROI) at each time point. The Individual ROI method uses the average of the 4 individual ROIs, one selected for each liver slice. The Common ROI method uses the area where those individual ROIs overlap. Comparing the two approaches assesses whether the selected way of defining the measured liver area is associated with different stiffness summaries.
The registry record identifies the endpoint summary as a mean and a standard deviation. It describes the mean as the overall mean of the data and the standard deviation as the within-participant standard deviation. The latter is relevant to repeatability because it describes variability within participants across repeated measurements. The numerical mean and within-participant standard deviation are not reported in the registry record, so the magnitude of measured stiffness or its observed variability cannot be interpreted from this record alone. The record also does not report a threshold for acceptable repeatability or a criterion for selecting between the ROI methods.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study designed to examine repeated MRE liver stiffness measurements, but it does not report the numerical endpoint estimates in the information available for this interpretation. In particular, the mean stiffness values and within-participant standard deviations for the Individual ROI and Common ROI approaches are not reported in the registry record. Without those estimates, it is not possible to characterize the observed measurement variability or to say whether one ROI approach produced more repeatable measurements.
The distinction between a study objective and a study finding is important. The objective was to assess repeatability in healthy volunteers and HCV-infected patients with fibrosis. The endpoint description gives the measurement procedures and the intended summaries. Neither description establishes what the results were. The registry record lists 4 outcome measures and 8 analyses, but does not give the numerical results, confidence intervals, or p-values for those analyses in the registry record. It is therefore not possible to assess the size or precision of the observed differences between the ROI methods.
This is a single-group, nonrandomized study with no masking. The primary comparison is between two ROI measurement approaches, not between an MRE group and a control group. The design can be relevant to measurement repeatability, but it does not support a causal comparison of clinical treatments. It also does not, from the design description alone, establish how MRE measurements relate to biopsy findings or whether MRE can replace biopsy. Such validation outcomes are not reported in the registry record.
The enrollment listed is 10, while the analysis population is described as completers. The actual number of completers, the number contributing to each outcome, and the distribution of participants between healthy volunteers and HCV-infected patients with fibrosis are not reported in the registry record. Consequently, the available description does not permit a subgroup interpretation or a precise assessment of how broadly the results would apply even if numerical estimates were available.
The record’s sample-size assumptions describe planning illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. Those hypothetical assumptions do not describe this single-group study’s design. Any planning illustration is not observed power and does not substitute for reported estimates and their precision. The planning outputs are not reported in the registry record details available for interpretation.
The appropriate conclusion is therefore limited: the registry record documents a repeatability study design and specifies how stiffness was measured and summarized, but it does not report the numerical results needed to judge repeatability. It cannot support a claim that measurements were highly or poorly repeatable, nor a conclusion that one ROI method was superior.
9. Statistical Methods Explained
The primary endpoint is a continuous measurement: maximum liver elastic stiffness in kPa. The registry record identifies the reported summaries as a mean and a within-participant standard deviation. These statistics address different questions. The mean describes the central level of stiffness across the measurements included in an analysis. The within-participant standard deviation describes how much repeated measurements vary within participants. For a repeatability study, that within-participant variation is particularly important because similar repeated readings are the property being examined.
What does repeatability describe?
In general, repeatability concerns the consistency of repeated measurements made under comparable conditions. It is a measurement property, not a test of whether the measurement is clinically correct. A method can produce consistent readings without necessarily agreeing with a reference standard, and agreement with a reference standard is a different question from consistency across repeated readings. The study objective concerns repeatability; the registry record does not report a numerical estimate of that property.
Repeated observations from the same participant are related: they share characteristics of the participant and are not equivalent to measurements from unrelated individuals. General statistical methods for repeated measurements need to account for that dependence when estimating uncertainty. The endpoint description states that the standard deviation was within participant, but the registry record does not describe the model or computational procedure used to obtain it. It would be inappropriate to infer a particular repeated-measures model, variance-components method, or other analysis from the outcome description alone.
How do the ROI approaches differ?
The reader evaluated 4 sections of the liver at 4 different time points. The Individual ROI approach averages the 4 separately selected ROIs, one for each liver slice. The Common ROI approach uses their common overlap. These are two operational definitions of the area used to measure stiffness. A difference between their summaries could reflect how the region is defined, but the record does not provide the numerical comparisons needed to assess that possibility. Nor does it state a decision rule for choosing one approach over the other.
The endpoint description says the overall mean and within-participant standard deviation were the summaries of interest. In general, an estimated mean communicates the average level of the continuous outcome, whereas a standard deviation describes spread rather than uncertainty in the mean. A confidence interval, if reported, would address uncertainty around an estimate and would be interpreted in relation to the analysis assumptions. No confidence intervals are reported in the registry record details available for this interpretation. The standard deviation should not be mistaken for a confidence interval or for a measure of diagnostic accuracy.
What can a comparison establish?
Comparing Individual ROI and Common ROI measurements can inform whether the measurement approach is associated with different values or variability under the study conditions. It is not a randomized treatment comparison. Because this is a single-group, nonrandomized study with no masking, the design description does not establish a blinded comparison or a control-adjusted treatment effect. The registry record does not report a specific statistical test, an adjustment model, a prespecified contrast, or the results needed to evaluate an inferential comparison.
In general, a p-value addresses how compatible observed data are with a specified statistical null model, given the assumptions of the analysis. It is not a measure of the size or clinical importance of an effect. A confidence interval gives a range of values compatible with the data and analysis under its assumptions, and can help convey precision. Neither p-values nor confidence intervals for the primary endpoint are reported in the registry record. No inference should be reconstructed from the endpoint title or from the count of analyses.
Why does variation matter?
General measurement theory distinguishes variation within a participant from variation between participants. Within-participant variation reflects inconsistency across repeat readings for the same person under the conditions studied; between-participant variation reflects differences among people. A within-participant standard deviation helps describe the first type, but it does not by itself show whether a measurement can distinguish clinically meaningful states or classify individuals accurately. A repeatability estimate also depends on the acquisition, reader, timing, and analysis conditions. The record describes the reader’s ROI process and a 14-day timeframe but does not report enough technical detail to characterize all of those conditions.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. If a model underestimates variability, uncertainty can appear too small. That concept is not evidence that over-dispersion occurred in this study: the registry record does not describe a model or report diagnostics that would allow such an assessment. Likewise, the record does not report whether the data were normally distributed or whether assumptions were checked.
The record lists 4 outcome measures and 8 analyses. In general, examining multiple outcomes or analyses can create multiplicity: the chance of at least one apparently noteworthy result can increase when many hypotheses are tested. Statistical plans may address this with a hierarchy, adjustment, or a clearly designated primary analysis. The registry record identifies a primary endpoint but does not report a multiplicity strategy, the relationships among the analyses, or which numerical findings correspond to which comparisons. It is therefore not possible to determine whether or how multiplicity was handled.
The sample-size assumptions describe planning illustrations using two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect defined as a stated fraction of an observed effect. These are planning assumptions, not the design of this single-group repeatability study. In general, sample-size calculations depend on the intended estimand, variability, allocation, and analysis assumptions. The registry record does not report a study-specific sample-size justification, and planning illustrations do not constitute observed power or evidence about the precision of the study’s results.
Overall, the endpoint description supports an explanation of what was intended to be measured and how the ROI summaries were formed. It does not provide the estimates, uncertainty, inferential procedures, or diagnostics needed to reproduce or evaluate the statistical conclusions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies participants analyzed as completers. It lists enrollment of 10, but does not report the number of completers or the number included in each endpoint analysis. It also does not report participant-level reasons for not completing, the extent of missing measurements, or whether missingness differed by participant group or ROI method. The analysis population therefore cannot be reconstructed from the registry description.
Missing-data handling is not reported in the registry record. In particular, the record does not state whether incomplete repeated measurements were excluded, whether an imputation method was used, or whether analyses were restricted to participants with complete data. These choices can affect what a summary estimates. For example, a complete-case analysis describes participants with the required measurements and may not represent everyone enrolled if completion is related to measurement values or participant characteristics. This is a general consideration, not a claim about what happened in this study.
The record lists 4 outcome measures and 8 analyses and identifies a primary endpoint. It does not report how the analyses were organized, which comparisons were designated in advance, whether a hierarchy was used, or whether a multiplicity adjustment was applied. In general, interpreting many analyses without knowing their prespecified roles can make isolated findings difficult to distinguish from results arising through repeated testing. No conclusion about the study’s actual multiplicity handling is possible from the information reported.
Analysis populations beyond completers are not reported in the registry record. The record also does not specify whether all enrolled participants were included in the safety summaries, although it gives the number at risk for those summaries. A detailed account of participant flow, missingness, exclusions, and analysis-set definitions would be needed to assess how the reported summaries relate to the enrolled population.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Magnetic Resonance Elastography (MRE) | 0 | 10 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Magnetic Resonance Elastography (MRE) | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Magnetic Resonance Elastography (MRE) |
|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | 1 of 10 |
| Nephrolithiasis | Renal and urinary disorders | 1 of 10 |
| Red blood cells urine positive | Investigations | 1 of 10 |
The registry record lists a single MRE group for the adverse-event summaries, with 10 participants at risk for serious adverse events and 0 affected. It lists 10 at risk for other adverse events and 1 affected. These are counts in the registry record; they should be read with their stated group and denominators rather than converted into percentages or treated as estimates of risk beyond this study.
The record does not list specific serious adverse-event terms. Deaths are not reported in the registry record. The adverse-event counts alone do not establish whether an event was caused by MRE, whether it was related to a study procedure, or how severe the non-serious event was. The registry record does not provide those details in the registry record for interpretation.
Safety summaries should be considered in the context of the study’s design and analysis population. The record describes participants analyzed as completers, but does not report the number of completers or provide a fuller account of how participants were followed for safety. These counts describe the recorded observations in this study; they do not establish the absence of unrecorded events or characterize safety in populations beyond those studied.
12. What the Result Does, and Does Not, Mean
This study addresses a measurement question: whether MRE-derived liver stiffness readings are repeatable under the procedures described, and whether results differ when the reader uses Individual ROI or Common ROI definitions. The registry record explains the intended measurement process and identifies the mean and within-participant standard deviation as summaries. However, the numerical endpoint findings are not reported in the registry record. As a result, the posted information does not establish whether repeatability was strong or weak, or whether the ROI approaches produced similar or different values.
The study’s stated purpose includes laying groundwork for validation of MRE as an alternative to liver biopsy. Groundwork is not itself validation. The record does not report a comparison with biopsy, diagnostic accuracy, agreement with a reference standard, or a criterion for replacing biopsy. It therefore cannot establish that MRE can or cannot serve as an alternative to biopsy.
The design is single-group, nonrandomized, and unmasked, with enrollment of 10. The intended population includes healthy volunteers and HCV-infected patients with fibrosis, but group counts and subgroup results are not reported in the registry record. The analysis population is described as completers, without a reported completer count. These omissions limit assessment of the populations represented and of how precisely any subgroup-specific measurement properties might be estimated.
The findings also should not be interpreted as a treatment effect. The study evaluates an MRE procedure and two measurement approaches, not randomized assignment to different clinical treatments. No control arm is described. The record does not report whether the measurement values predict clinical outcomes or how they should inform clinical decisions. Those questions go beyond the repeatability objective and are not answered by the available results.
In short, the registry record establishes the study’s scope and measurement definitions, but not its numerical repeatability findings. Any conclusion about the quality of MRE measurements, the relative performance of the ROI approaches, diagnostic usefulness, or substitution for biopsy would require results and validation evidence not reported in the registry record.
13. Why This Trial Matters Statistically
Repeatability is a foundational measurement property. If repeated readings vary substantially under comparable conditions, it can be difficult to distinguish a real change from measurement noise. If measurements are consistent, that supports their reliability under the conditions tested, but does not on its own establish that they measure the intended clinical construct accurately. These are general principles of measurement, not conclusions about the results of this study.
This study’s design makes the distinction especially relevant. It examines repeated liver stiffness measurements by MRE and compares two ways of defining the region used for measurement. That focus can help clarify how measurement choices contribute to observed variability. The record describes the ROI methods and within-participant standard deviation, but it does not report the numerical estimates needed to quantify repeatability or compare those methods.
The study also illustrates why a clinical objective should be separated from a validation claim. The stated aim was to assess repeatability in healthy volunteers and HCV-infected patients with fibrosis and lay groundwork for validation as an alternative to biopsy. Establishing repeatability is not the same as demonstrating accuracy against biopsy or showing that a measurement can replace it. The registry record does not report those validation results.
For biostatistical interpretation, the record also highlights the importance of transparent reporting: numbers analyzed, missing-data handling, analysis methods, uncertainty estimates, and the relationship among multiple analyses. The record lists enrollment of 10, describes completers as the analysis population, and lists 4 outcome measures and 8 analyses, but does not report the detailed numerical findings or the analysis details needed to assess precision and multiplicity.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation for interpreting the posted record is that it does not report numerical results for the primary endpoint. The mean stiffness values and within-participant standard deviations are not reported in the registry record, nor are the numerical comparisons between Individual ROI and Common ROI. Without those estimates, the central repeatability question cannot be answered from the registry information available for this interpretation.
The registry record lists enrollment of 10, but describes the analyzed population as completers without stating the number of completers. It does not report how many participants were healthy volunteers and how many were HCV-infected patients with fibrosis, or whether each group had separate results. The number contributing to each analysis and the extent of missing measurements are also not reported.
The study is nonrandomized, unmasked, and single group. These features fit a repeatability investigation but do not provide a like-for-like randomized control comparison. The record does not report the technical acquisition details, reader training, prespecified acceptability criteria, or a detailed statistical analysis plan. It also does not report how multiplicity, missing data, or uncertainty was handled.
The primary outcome timeframe is 14 days, and the described reading process uses repeated measurements, but the record does not give enough detail to judge whether all conditions were held constant or how representative the observed measurement conditions were of other settings. The record also does not report biopsy comparisons or diagnostic validation results. These limitations restrict interpretation to the study’s stated measurement objective and prevent conclusions about accuracy, clinical usefulness, or replacement of biopsy.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED) — NCT00896233.
- Registry record last updated 2015-08-25; status last verified 2015-08.
- Results first posted 2011-09-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00896233 is a completed Phase 1, nonrandomized, unmasked, single-group study of MRE for liver fibrosis assessment. Enrollment is listed as 10. The intended population included healthy volunteers and HCV-infected patients with fibrosis. The primary outcome was repeated maximum liver elastic stiffness in kPa over 14 days, summarized by an overall mean and within-participant standard deviation.
The outcome description compares Individual ROI and Common ROI approaches after a reader evaluated 4 liver sections at 4 different time points. The record identifies completers as the analyzed population, but does not report their number or the numerical endpoint results. It lists 4 outcome measures and 8 analyses without the detailed estimates needed to assess repeatability.
Safety summaries list 0 of 10 participants affected by serious adverse events and 1 of 10 affected by other adverse events in the MRE group. Specific serious-event terms and deaths are not reported in the registry record. The study objective and design are documented, but numerical findings and several analysis details needed for a fuller statistical interpretation are not reported.