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 Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation (NCT02348684), a registered phase not stated study. The primary outcome is Cardiac MRI Parameters.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02348684 |
| Phase | Phase not stated |
| Condition | Node Positive Breast Cancer |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medical College of Wisconsin |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns women treated for node-positive breast cancer. The registry record describes the study as a pilot and reports enrollment of 20 participants. It does not report further eligibility details or characteristics of the participants, so the population represented by the results cannot be described more precisely from the registry record.
Intervention
The intervention is listed as radiation therapy groups. The official title specifies three-dimensional conformal radiation therapy, and the group descriptions say that risk groups were based on dosimetric radiation parameters. The registry record does not specify the radiation doses, the parameters used to define the groups, or the group thresholds.
Comparator
The record does not describe a randomized comparison. Allocation is not stated, and the listed groups are not a like-for-like control comparison. The registry record does not identify an untreated control group or provide enough detail to determine how the radiation risk groups differ from one another.
Primary question
The primary outcome is titled “Cardiac MRI Parameters” and is described as the number of patients, assessed on the day of the MRI scan. The listed parameters include left ventricular ejection fraction, indexed left ventricular mass, left ventricular dimensions, extracellular volume, and late gadolinium enhancement. The question is how these cardiac MRI parameters relate to the radiation dosimetric groupings. The registry record does not report numerical outcome results or analyses answering that question.
3. Trial Design
The registry record describes a completed pilot study of cardiac function assessed with cardiac MRI and related to radiation dosimetry. Its official title identifies women treated for node-positive breast cancer with three-dimensional conformal radiation therapy. The record reports enrollment of 20 participants and lists Medical College of Wisconsin as the sponsor. The study began in 2012-03, reached primary completion in 2014-11, and has status COMPLETED.
The intervention entry is “Radiation therapy groups.” Its arm description characterizes the groups as risk groups based on dosimetric radiation parameters. The record does not describe the group definitions, how many groups there were, the number of participants in each group, or the radiation exposure values used to classify participants. Allocation is not stated. The registry record also indicates that these groups are not a like-for-like control comparison, so the design should not be interpreted as a randomized trial contrasting treatment with an equivalent control condition.
The primary outcome is “Cardiac MRI Parameters,” with the unit given as number of patients and the timeframe as the day of the MRI scan. A secondary outcome is to correlate cardiac MRI parameters. The primary outcome description names several MRI measures, but does not give separate numerical results for them. The registry record reports two outcome measures but no analysis entries. It does not report a statistical analysis plan, the timing of any additional assessments, or how participants were assigned to the dosimetric groups.
These omissions limit what can be concluded about the study design and its comparisons. The record supports describing the study as a completed pilot involving cardiac MRI and radiation dosimetry; it does not support reconstructing unreported procedures or making claims about the study’s findings.
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
| Stage | Radiation Therapy Groups |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
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 | Radiation Therapy Groups |
|---|---|---|
| Participants analysed | 20 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 14 |
| Age, Categorical: >=65 years | Participants | 6 |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Cardiac MRI Parameters, measured over day of MRI scan.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of patients |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Cardiac MRI Parameters.” It is recorded as a number of patients, with assessment on the day of the MRI scan. The description lists left ventricular ejection fraction, indexed left ventricular mass, left ventricular dimensions, extracellular volume, and late gadolinium enhancement. These measures capture different features of cardiac structure or imaging characteristics; the registry record does not state how each was summarized, what constituted an abnormal result, or whether the measures were analyzed separately or combined.
In general, cardiac MRI can provide quantitative measurements of cardiac structure and function. Such measures can be used to describe cardiac status and explore whether it varies with an exposure measure, such as radiation dosimetry. A study relating MRI measurements to dosimetric risk groups can therefore address whether patterns in the imaging measures accompany differences in recorded radiation exposure. That association is not, by itself, proof that exposure caused a change.
The endpoint description names the measures but does not provide observed values, group-specific counts, effect estimates, confidence intervals, or tests of association. The registry record also does not report a threshold or a single composite definition for the primary endpoint. Consequently, the registered endpoint can be described, but its results and the precision of any estimated relationship cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s topic, population, stated outcome, and broad grouping approach, but it does not provide outcome analyses. It reports enrollment of 20 participants and identifies cardiac MRI parameters measured on the day of the MRI scan as the primary outcome. It also describes radiation risk groups based on dosimetric parameters. However, there are no posted analysis entries and no reported numerical outcome results. The record therefore does not establish whether MRI measurements differed across groups or whether any association was observed.
The primary endpoint is broad: it includes left ventricular ejection fraction, indexed left ventricular mass, left ventricular dimensions, extracellular volume, and late gadolinium enhancement. Because no measure-specific results or analysis definitions are reported, the reader cannot determine how the measures were handled, whether they were considered individually, or what a clinically meaningful difference would have been. The record gives no estimates with which to assess the size or precision of a relationship.
In general, an estimate describes the observed relationship in a study, while a confidence interval describes the range of values compatible with the data under the method’s assumptions. Neither can be interpreted without reported results. A lack of posted analyses is not evidence that the groups had the same outcomes; it means the registry record does not supply the estimates needed to judge whether the data suggest a difference or how uncertain that assessment would be.
The group structure also constrains interpretation. Allocation is not stated, and the record explicitly says that the arms are not a like-for-like control comparison. Any observed association, if one were reported elsewhere, would need to be interpreted in light of how dosimetric groups were defined and how participants differed across those groups. The registry record does not describe those details or report adjustment for other factors.
The study’s completed status and pilot designation do not substitute for outcome reporting. They indicate the recorded study status and stated study type, not the direction or strength of any cardiac MRI finding. The posted record permits a description of the research question, but does not support a conclusion about the observed relationship between radiation dosimetry and cardiac MRI parameters.
9. Statistical Methods Explained
The registry record names a count-based primary outcome: the number of patients associated with cardiac MRI parameters. It does not provide a statistical analysis plan, analysis entries, estimates, or uncertainty measures. The methodological explanations below are general; they describe how such data can be approached, not methods confirmed to have been used in this study.
What does a count represent?
In general, a count records how many participants meet a defined condition. A count alone is difficult to interpret without its denominator and a clear definition of the condition. For example, a count of participants with a specified MRI finding would require a stated rule for classifying that finding and the number of participants assessed. The registry record gives the outcome unit as number of patients, but does not report a threshold, event definition, or observed count for any of the listed MRI measures.
The record also describes several continuous or imaging-based measurements, including ejection fraction, indexed mass, dimensions, and extracellular volume. In general, measurements of this kind may be summarized by their distribution and compared across groups, while categorical findings may be summarized as counts and proportions. The choice depends on the outcome’s scale and the scientific question. The registry record does not say which summary or model was used for any parameter.
Why does the grouping matter?
The arm description says risk groups were based on dosimetric radiation parameters. In general, a group comparison requires clear definitions of each group, including the exposure measure and classification rules. Without those details, the meaning of a difference between groups cannot be fully assessed or reproduced. The record does not report group cutoffs, participant counts by group, or the actual dosimetric values.
Grouping by an exposure measure is also different from random assignment. In general, randomization is designed to balance measured and unmeasured characteristics between comparison groups on average. When allocation is not stated and the groups are not a like-for-like control comparison, group differences could reflect exposure, other participant characteristics, or both. Statistical adjustment can sometimes address measured differences, but it cannot automatically remove bias from factors that were not measured or modeled. The registry record does not report adjustment methods.
How should estimates and uncertainty be read?
In general, an effect estimate gives the observed size and direction of a comparison or association. A confidence interval communicates uncertainty around that estimate under the statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval, but precision is not the same as freedom from bias. Because the registry record contains no estimates or intervals, the size, direction, and precision of any association cannot be evaluated.
For counts, the denominator and the number of observed events are central to interpretation. If counts are small, estimates can be imprecise, and ordinary model assumptions may be unsuitable. In general, over-dispersion occurs when observed variation exceeds what a chosen count model expects; ignoring it can make uncertainty appear smaller than it is. The record does not provide count data or identify a model, so it is not possible to assess whether over-dispersion or another modeling issue arose in this study.
What does the planning illustration mean?
The study’s sample-size assumptions are described as a planning illustration computed from the observed effect, rather than the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The record says that such illustrations give participants per arm for 80% power, except that time-to-event illustrations give total events.
In general, a planning calculation asks how much information a future study might need under specified assumptions. It is not an estimate of the probability that the completed study detected a real effect. A planning illustration based on an observed effect can also be sensitive to that estimate, especially when the original study is small or the estimate is uncertain. It should not be described as observed power or taken as evidence that the study was adequately sized for its actual design. The registry record does not report a sample-size justification for the study’s own design, and the stated illustration assumptions do not establish what planning process the investigators used.
No sponsor analysis is reported in the registry record. Accordingly, there is no sponsor result to compare with a recalculation from posted summary statistics, and no recalculated effect should be inferred from the enrollment or adverse-event entries.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes several cardiac MRI parameters, and the registry record also lists a secondary outcome to correlate cardiac MRI parameters. When a study evaluates multiple outcomes or multiple comparisons, the chance of at least one apparently notable result can increase if each is assessed independently. In general, a statistical plan may address this by defining a primary measure in advance, specifying a hierarchy, or adjusting the interpretation of multiple tests. The registry record does not report a multiplicity strategy, test hierarchy, or analysis plan. It also does not make clear whether the listed MRI parameters were each treated as separate outcomes or combined in a defined way.
Missing-data methods matter because participants may lack an MRI measurement or a particular parameter may be unavailable. In general, the amount and pattern of missing data can affect both estimates and their uncertainty. A complete-case analysis uses participants with the relevant observed data, while other approaches may use assumptions or models to account for missingness. The registry record does not report whether any outcome data were missing, how missingness was handled, or whether any participants were excluded from an analysis.
Analysis populations also need clear definitions. In general, a report should state which participants were included in each analysis and how that population relates to enrollment, group assignment, and outcome availability. The registry record gives enrollment of 20 but does not report analysis populations or participant flow. The absence of analysis entries means that neither the number analyzed nor the handling of withdrawals or exclusions is reported in the registry record.
These are reporting gaps, not evidence that multiplicity, missingness, or population definitions were mishandled. They prevent readers from determining how those issues were addressed.
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 |
|---|---|---|---|
| Radiation Therapy Groups | 0 | 20 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Radiation Therapy Groups | 0 of 20 |
The safety record lists a radiation therapy group with 20 participants at risk for serious adverse events and 0 affected. It also lists 20 at risk for other adverse events and 0 affected. No serious adverse-event terms are listed. Deaths are not reported in the registry record.
These figures describe the safety entries in the registry record. They do not provide event timing, participant-level details, duration of follow-up, or a definition of which events were counted. The record does not state whether the figures cover the entire study period or a particular assessment window. It also does not report a comparison with an equivalent control group.
In general, a zero in a safety field means that no affected participants are recorded for that field in the posted results; it does not demonstrate that an event is impossible or that the study could rule out uncommon harms. Safety interpretation depends on the number of participants observed, the length and completeness of follow-up, and the rules used to collect and classify events. Those details are not reported in the registry record. The listed figures should therefore be read as registry counts, not as a complete characterization of safety or as evidence about causation.
12. What the Result Does, and Does Not, Mean
The record describes a completed pilot study examining cardiac MRI parameters in women treated for node-positive breast cancer with three-dimensional conformal radiation therapy. It identifies radiation risk groups based on dosimetric parameters and names several MRI measures as the primary outcome. Those details establish the general research question: whether cardiac imaging measures can be related to recorded radiation dosimetry.
The record does not report the outcome values, group-specific results, estimates of association, confidence intervals, or analysis entries. As a result, it does not show whether the MRI parameters varied across dosimetric groups, how large any variation was, or how precisely a relationship was estimated. The absence of results cannot be interpreted as a finding of no difference or no association.
The record also does not establish that any observed imaging pattern, if reported elsewhere, was caused by radiation exposure. The allocation method is not stated, and the registry record says the groups are not a like-for-like control comparison. In general, a non-randomized exposure-group comparison can be influenced by differences between participants in addition to the exposure under study. Group definitions and relevant adjustment methods would be necessary to evaluate that concern, but are not reported in the registry record.
The study’s pilot designation and enrollment of 20 describe its recorded scope; they do not establish the adequacy of its design for a particular effect or determine the certainty of an unreported result. The safety entries record 0 affected participants for both serious and other adverse events, with 20 at risk in each field. Those entries are limited registry counts, not a complete statement about all possible safety outcomes.
Overall, the record documents a cardiac MRI and dosimetry research question, but does not provide the findings needed to judge the observed relationship or its precision.
13. Why This Trial Matters Statistically
This study raises a statistical question about how an exposure measured through radiation dosimetry can be related to several cardiac MRI parameters. That question matters because the interpretation depends not only on the imaging measurements, but also on how exposure groups are formed, how outcomes are defined, and how uncertainty is reported.
The registry record makes those issues visible. It identifies risk groups based on dosimetric parameters, but does not specify the parameters or classification rules. It names several MRI measures, but does not report how each was summarized or whether they were analyzed separately. It also states that allocation is not provided and that the groups are not a like-for-like control comparison. These features make clear why a group label alone is not enough to establish a causal contrast.
In general, transparent reporting of outcome definitions, analysis populations, missing data, and statistical methods helps readers distinguish a measured association from a causal effect. Reporting estimates with uncertainty also helps readers assess whether the evidence is precise enough to support a useful interpretation. Without those elements, the question may be clinically relevant while the registry record remains insufficient for judging its statistical answer.
The pilot designation is also important to interpret carefully. Pilot studies can inform measurement and study procedures, but the designation alone does not indicate the observed effect, the precision of an estimate, or whether the design was intended to test a definitive hypothesis. The registry record does not report a design-specific sample-size justification or outcome analyses.
Thus, the statistical importance of this record lies both in its stated imaging-and-dosimetry question and in the reporting information needed to evaluate that question. The available record documents the study framework but does not provide an answer about the relationship studied.
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.
Several limitations specific to this study follow from what the registry record reports and omits. The study is described as a pilot, and enrollment is 20. The record does not provide participant characteristics beyond the population of women treated for node-positive breast cancer, so the characteristics of those enrolled and the scope of applicability cannot be assessed from the registry entry.
The radiation groups are described only as risk groups based on dosimetric parameters. The definitions, thresholds, number of groups, and group sizes are not reported in the registry record. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. These limitations restrict interpretation of any group comparison and prevent reconstruction of the exposure contrast.
The primary outcome lists several cardiac MRI parameters but does not report measurement definitions, thresholds, observed values, or separate results. The record also contains no analysis entries, statistical plan, estimates, confidence intervals, or reported outcome population. Missing-data handling, multiplicity methods, and adjustment for other factors are not reported in the registry record.
The safety entries list no affected participants for serious or other adverse events, but provide no event terms, follow-up details, or deaths figure. These omissions limit the scope of safety interpretation. More broadly, a completed status does not indicate that results are available in the registry record. The record supports describing the study’s purpose and broad design, but not evaluating its findings or the precision and robustness of any estimated association.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation — NCT02348684.
- Registry record last updated 2026-04-01; status last verified 2026-03.
- Results first posted 2019-07-01.
- 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
The registry record describes a completed pilot study of cardiac MRI and dosimetric correlation in women treated for node-positive breast cancer with three-dimensional conformal radiation therapy. Medical College of Wisconsin is listed as sponsor. Enrollment was 20; the recorded start was 2012-03, primary completion was 2014-11, and status is COMPLETED.
The primary outcome is “Cardiac MRI Parameters,” assessed on the day of the MRI scan. Listed measures include left ventricular ejection fraction, indexed left ventricular mass, left ventricular dimensions, extracellular volume, and late gadolinium enhancement. Radiation therapy groups are described as risk groups based on dosimetric radiation parameters. Allocation is not stated, and the arms are not a like-for-like control comparison.
The record lists a secondary outcome to correlate cardiac MRI parameters. It contains no analysis entries or numerical outcome results. Safety entries list 20 at risk and 0 affected for serious adverse events, and 20 at risk and 0 affected for other adverse events. Serious-event terms are not listed, and deaths are not reported in the registry record.