A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver (NCT02966223), a na na study. The primary outcome is Primary.

2. Clinical Question

The study’s central question was whether Y-90 liver therapy is associated with a change in regional liver function. Its primary outcome was defined as the difference between pre-treatment and 3-month post-treatment regional function measured with HIDA functional imaging scans. The registry describes the study as enrolling patients planning to receive Y-90 therapy for liver malignancies; the listed conditions are HCC and liver cancer.

This is a within-group before-and-after question, not a randomized comparison of Y-90 with another treatment or with no treatment. The intended measurement focuses on liver function in regions of the liver, rather than only on tumor response. The study summary explains that the investigators sought to improve understanding of how Y-90 distribution relates to liver damage, against a background in which assumptions about Y-90 administration were based on other kinds of liver surgery and radiation treatment. The registry record does not report a completed analysis that answers the primary question.

3. Trial Design

The registry describes a single-group study with an enrollment of 20. Allocation is listed as NA, masking as NONE, and phase as NA. The study was conducted in the context of patients planning to receive Y-90 therapy for liver malignancies. The intervention entry is “MRI and HIDA scan,” with no further arm description recorded. The primary outcome description specifies HIDA functional imaging scans before treatment and 3 months after Yttrium 90 delivery.

Because the design has one group, the primary contrast is a change over time within participants, rather than a difference between randomized treatment groups. The registry does not identify a concurrent control group. It therefore does not describe a design capable of directly separating changes associated with Y-90 treatment from changes that could occur over time for other reasons. That distinction is important when interpreting any before-and-after result, even if such a result were available.

The record lists a start date of 2017-08-17 and a primary completion date of 2019-07-15. Its status is TERMINATED. The primary-outcome population description states that the trial was halted prematurely because the sponsor withdrew funding and that there was insufficient data because funding to perform the analysis was withdrawn. No primary outcome estimate or analysis is reported in the registry record.

The study summary describes Y-90 as radioactive particles administered to liver tumors through a catheter placed in a hepatic artery supplying the tumor. It also describes post-treatment PET/CT as a way to assess Y-90 distribution. However, PET/CT is not identified as the primary functional outcome measure: that outcome is defined using HIDA scans. The registry record does not report additional details about treatment delivery, timing of the scans beyond the primary timeframe, or procedures for interpreting images.

The entry lists two secondary outcomes, but their names and results are not reported in the registry record. The total number of outcome measures is listed as 3, while no analysis records are listed. These entries do not supply the missing primary analysis or clarify what statistical procedures were used.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The trial was halted prematurely because sponsor withdrew funding. There is insufficient data as funding to perform the analysis was withdrawn.

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.

Population: The trial was halted prematurely because sponsor withdrew funding. There is insufficient data to analyze. Inclusion criteria to participate in study being 18 years of age and older, Hepatocellular Carcinoma diagnoses and treatment plan to undergo radioembolization Y90 therapy, and not pregnant or planning to become pregnant during study.

6. Primary Endpoint

The registry lists the primary outcome as Primary, measured over 3 months.

The primary endpoint is the difference in regional liver function between the pre-treatment assessment and the assessment 3 months after Yttrium 90 delivery, measured with HIDA functional imaging scans. It is a functional imaging outcome: it is intended to describe how well regions of the liver function, rather than to measure only the amount of tumor or the distribution of particles.

In general, a pre-treatment measurement gives a reference point for interpreting a later measurement in the same participant. A regional measure may be useful when the study question concerns changes across parts of the liver, since a whole-organ summary can conceal variation between regions. HIDA functional imaging is the measurement approach named in this registry outcome. The registry does not give a detailed explanation of the imaging metric, its units, how regions were defined, or how the scans were converted into a numerical outcome.

The stated comparison is between pre-treatment function and function at 3 months. A complete report would normally make clear whether the endpoint is expressed as a signed change, a magnitude of change, or another contrast, and would give a summary estimate with uncertainty. Those details and the primary result are not reported in the registry record. The record instead states that the trial was halted prematurely after sponsor funding was withdrawn and that there was insufficient data to perform the analysis. Consequently, the intended endpoint can be described, but its observed value and precision cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record does not describe a completed statistical analysis for the primary outcome. The endpoint is named, but no analysis estimate, uncertainty interval, hypothesis test, or analysis population is reported. The distinctions below explain general statistical concepts relevant to the stated before-and-after question; they should not be read as methods confirmed to have been used in this study.

What a within-participant change represents

For a participant with both a pre-treatment and a 3-month measurement, a change score is based on comparing those two measurements. In general, analyzing paired observations preserves the fact that the measurements come from the same person. The two observations are usually related: participants with higher baseline values may also tend to have higher follow-up values. Accounting for this pairing can describe change more appropriately than treating all baseline and follow-up observations as unrelated.

Several possible summaries could describe such paired data. A mean change describes the average signed difference if the outcome is numeric and the analysis uses that summary. A median or another summary could be used when the distribution or the scientific question makes it more appropriate. A model could also estimate the average time-related change while accounting for repeated observations. The registry does not report which summary or model was planned or used, nor does it give enough detail about the outcome scale to identify a particular method.

What uncertainty adds

A point estimate alone would not show how precisely the change has been estimated. In general, a confidence interval gives a range of values reasonably compatible with the observed data and the assumptions of the analysis. A wider interval indicates less precision than a narrower interval. For this study, no estimate or confidence interval for the primary outcome is reported in the registry record, so its precision cannot be evaluated.

A hypothesis test, if conducted, would address a specified statistical question under stated assumptions. Its result would not replace the estimated size of change or its uncertainty. The registry does not report a primary hypothesis, a significance threshold for the outcome analysis, a test statistic, or a p-value. None should be inferred from the fact that the endpoint was designated primary.

Missing observations and analysis populations

A paired analysis generally requires both measurements for a participant, unless a method capable of using incomplete repeated measurements is specified. If some participants lack a follow-up scan, an analysis restricted to complete pairs may represent a subset of those enrolled. Other approaches can use incomplete measurements under particular assumptions. Those approaches differ in what they estimate and in how they rely on assumptions about missingness. The registry does not report the number of participants with both scans, the reasons for missing observations, the method for handling missing data, or the analysis population.

Enrollment of 20 therefore cannot be interpreted as the number analyzed for the primary endpoint. It also cannot establish that each participant completed both imaging assessments. The registry explicitly says there was insufficient data to perform the analysis after funding was withdrawn, but it does not provide a participant flow or scan-completion count. The extent and pattern of missing outcome data are not reported in the registry record.

Design and causal interpretation

In general, measuring participants before and after treatment can reveal a temporal difference in the measured outcome. A single-group design, however, does not include a separate group to represent what would have happened over the same period without the treatment. This means a change over time cannot automatically be attributed solely to Y-90 therapy. A controlled design may address some alternative explanations, but the registry describes no randomized comparison and lists a single group. It does not report an adjustment strategy intended to address time-varying influences.

The study summary discusses comparing Y-90 distribution with liver function and mentions post-treatment PET/CT as a means of assessing distribution. These descriptions indicate scientific context, not a reported statistical model. The registry does not identify a dose-response model, a regional analysis method, covariates, or a strategy for handling multiple regions within a participant. Regional observations can be correlated within a person, so treating them as independent would require justification. Whether the study planned to analyze regions separately or in a combined model is not reported in the registry record.

Planning illustrations

The registry includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as stated fractions of an observed effect. It also distinguishes between total events for time-to-event illustrations and participants per arm for other illustrations. These are planning assumptions, not a description of the actual single-group trial design. The record does not report a trial-specific sample-size justification or the numerical planning estimates. The stated two-arm planning setup should not be mistaken for evidence that participants were assigned to two arms in this study.

In general, sample-size calculations depend on assumptions about the outcome, variability, target effect, significance level, allocation, and analysis. A planning calculation is not observed power and does not show what the trial found. An illustration based on an observed effect also cannot substitute for the missing primary analysis. Since the registry reports that the analysis could not be performed, no completed outcome estimate or corresponding precision assessment can be reconstructed from the information in the record.

Finally, the presence of a primary endpoint label does not establish that all analysis decisions were prespecified or that a particular statistical method was carried out. Details such as the analysis model, treatment of outliers, assumptions checks, confidence interval method, and any interim analyses are not reported in the registry record. They should remain unknown rather than being inferred from common practice.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists two secondary outcomes, but the secondary outcome names and results are not reported in the registry record. It does not describe a strategy for controlling multiplicity across outcomes, regions of the liver, time points, or statistical tests. Multiplicity matters in general because conducting several tests can increase the chance of obtaining at least one apparently notable result by chance. Whether that concern arose in the planned analysis cannot be determined without the analysis plan and results.

The primary outcome is described as a pre-treatment versus 3-month comparison. No other primary time points are stated. The registry does not report whether there were additional measurements, exploratory analyses, subgroup analyses, or repeated comparisons across liver regions. Their existence and any adjustment for them are not reported in the registry record.

Missing-data information is also limited. The record says the trial was halted prematurely after the sponsor withdrew funding and that there was insufficient data to perform the primary analysis. It does not report the number of participants with paired scans, the number included in any analysis, reasons for missing measurements at the participant level, or methods for handling missing values. It therefore is not possible to assess whether missingness could have influenced an estimate.

The registry does not define an analysis population, such as all enrolled participants or participants with evaluable imaging. Although enrollment is 20, that count should not be assumed to be the denominator for the primary outcome analysis. The exact analysis population and the handling of participants without complete data are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s safety group is titled MRI and HIDA Scan. It records 20 participants at risk, zero participants with serious adverse events, zero with other adverse events, and zero deaths. These figures are counts in the posted record; they are not an estimate of the primary functional outcome and do not address whether regional liver function changed.

A zero count should be read narrowly: the registry reports no events in these categories for the listed group. It does not establish that events were impossible, that every participant had complete safety follow-up, or that all events were captured. The record does not provide the observation period for safety reporting, event definitions, participant-level follow-up completeness, or additional descriptions of events. The number at risk is recorded as 20, but the extent of safety monitoring cannot be inferred from that count alone.

These descriptive counts also do not support a comparison with another treatment or an untreated group, because the study is listed as single-group and no comparator group is reported. In general, rare events may not be well characterized in a small group, and observed counts depend on the amount and completeness of follow-up. The posted zero counts should therefore be understood as registry-reported counts, not as proof of absence of risk or as a comparative safety conclusion.

12. What the Result Does, and Does Not, Mean

The study was designed to examine a relevant measurement question: whether regional liver function differed between before Y-90 delivery and 3 months afterward. The registry gives the intended measure, HIDA functional imaging, and places the work in the context of uncertainty about the relationship between Y-90 therapy and liver damage. It also describes PET/CT imaging as a means of assessing Y-90 distribution. These are objectives and rationale, not evidence of an observed result.

The central result is unavailable in the registry record. The record states that the trial was terminated after the sponsor withdrew funding and that there was insufficient data to perform the primary analysis. It does not report an estimate of change, its direction, its magnitude, or its precision. As a result, the posted information cannot show whether regional function changed, how much it might have changed, or whether a measured change could be distinguished from random variation.

The record also cannot establish that Y-90 caused any change. The study is listed as single-group, with no randomized comparator. In general, a before-and-after comparison describes change over time among measured participants; without a concurrent comparison group, other influences over time cannot be ruled out solely from that contrast. The absence of a completed analysis further prevents even a descriptive estimate of change from being evaluated.

The safety counts report zero serious adverse events, zero other adverse events, and zero deaths among 20 participants at risk in the listed group. Those counts should be interpreted as registry entries, not as a comprehensive guarantee of safety or as evidence about functional benefit. Details about follow-up and event capture are not reported.

In short, the record documents an intended single-group imaging study, its primary endpoint, its enrollment, and its early termination. It does not provide the outcome evidence needed to determine what happened to regional liver function in the study participants. Neither a positive nor a negative conclusion about the primary question is supported by the posted results.

13. Why This Trial Matters Statistically

This study raises a statistical measurement question that goes beyond whether a treatment was delivered: how should regional liver function be assessed before and after treatment, and how can that measurement be related to treatment distribution? The registry’s primary endpoint focuses on regional function using HIDA scans, while the study summary describes PET/CT as a method for assessing Y-90 distribution. These distinct measurement aims illustrate why outcome definition and measurement timing matter in clinical research.

The before-and-after design also makes clear the difference between describing change and establishing its cause. A paired comparison can use repeated measurements from the same participant, but without a separate comparison group it cannot by itself distinguish treatment-associated change from other changes over time. This is a general design issue, not a conclusion about the direction or size of any change in this study; the registry reports no completed primary analysis.

The record further illustrates why enrollment is not the same as an analyzable sample. It lists 20 enrolled participants, yet states that there was insufficient data to perform the primary analysis after funding was withdrawn. The number with usable paired scans and the reasons for missing data are not reported. Without those details, neither the effective analysis population nor the likely precision of an estimate can be assessed.

Finally, a planned endpoint and a planning illustration do not stand in for results. The record gives a primary outcome definition and general sample-size assumptions, but it does not report the primary estimate or its uncertainty. The statistical importance of the study therefore lies in the question and the design constraints it exposes, while the empirical answer remains unavailable in the registry record.

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 most direct limitation is that the registry reports no primary outcome analysis. It states that the trial was halted prematurely because the sponsor withdrew funding and that the available data were insufficient to perform the analysis. No result for regional liver function, measure of variability, or confidence interval is reported. This prevents assessment of the size, direction, and precision of the intended outcome.

The study is listed as a single-group design, with allocation marked NA and masking listed as NONE. No control group is described. Even if a complete before-and-after estimate were available, the design would limit attribution of a temporal difference to Y-90 therapy alone. The record does not report an adjustment plan that would address alternative explanations.

Enrollment is recorded as 20, but the number with complete pre-treatment and 3-month HIDA scans is not reported. Participant flow, reasons for missing scans, analysis populations, and missing-data methods are not reported in the registry record. Because the trial was terminated before the analysis could be performed, the relationship between enrollment and analyzable data is particularly important but remains unclear.

Other endpoint details are also absent. The record does not specify the functional metric’s units, how liver regions were defined, how imaging measurements were processed, or how regional observations were handled statistically. The secondary outcomes are not named in the results record, and methods for addressing multiple outcomes or analyses are not reported. Details of treatment delivery and scan interpretation are also limited.

Safety information is restricted to the listed event counts and does not include follow-up completeness or additional event descriptions. These limitations mean the registry supports a description of the planned question, design, termination, and recorded counts, but not a complete assessment of efficacy, functional change, or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver — NCT02966223.
• Registry record last updated 2020-09-25; status last verified 2020-09.
• Results first posted 2020-09-25.
• 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.

18. Record Summary

NCT02966223 is a single-group study titled “A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver.” The registry lists an enrollment of 20, phase NA, allocation NA, and masking NONE. The primary endpoint is the difference in regional liver function before and 3 months after Yttrium 90 delivery, measured with HIDA functional imaging scans.

The record lists a start date of 2017-08-17, a primary completion date of 2019-07-15, and status TERMINATED. It states that the trial was halted prematurely because the sponsor withdrew funding and that there was insufficient data to perform the primary analysis. No primary outcome estimate is reported. The safety group lists 20 at risk, zero serious adverse events, zero other adverse events, and zero deaths. The registry does not report the analysis population, scan completion counts, or a completed statistical analysis.