Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer (NCT01303419), a na na study. The primary outcome is Completion of CE-BMRI and DE-CEDM.

2. Clinical Question

The registry describes a multicenter, open-label, crossover study in women with newly diagnosed breast cancer. The planned sequence was bilateral CE-BMRI within 30 days after diagnosis, followed by bilateral DE-CEDM up to 8 weeks after CE-BMRI. Because the same participants were intended to undergo both examinations, the study is not described as a comparison between independent treatment groups.

The practical question suggested by the title is whether DE-CEDM can identify changes in patient management comparably to CE-BMRI. The available registry information does not report a numerical comparison of management changes, a non-inferiority margin, or an analysis supporting that claim. The listed primary endpoint instead asks whether participants completed both scans. Completion can describe whether the planned imaging sequence was carried out, but it is not a direct measure of agreement or comparative diagnostic performance.

Accordingly, the registry record supports describing the study’s population, imaging sequence, and stated purpose, but it does not support a conclusion about the comparative management information from the two tests. The distinction between the title’s question and the recorded endpoint is central to interpreting what the available results can establish.

3. Trial Design

The registry lists this as a single-group, open-label study with no masking. Allocation is recorded as NA, and the record explicitly indicates that this is not a randomized comparison. The official title uses the term crossover, and the study description sets out a within-participant sequence: bilateral CE-BMRI followed by bilateral DE-CEDM. The examinations were therefore planned as sequential assessments in the same participants, not as separate randomized groups receiving different imaging approaches.

The registry describes CE-BMRI as usual clinical practice within 30 days after a breast cancer diagnosis. Participants were then to undergo DE-CEDM within 8 weeks after the CE-BMRI examination. The primary endpoint timeframe is approximately 8 weeks, and the endpoint is the count of participants completing both examination types. The registry describes the enrolled population as women with newly diagnosed breast cancer.

The study lists 224 participants as enrolled. Its phase is recorded as NA. The recorded status is terminated, and the primary completion date is 2012-06-30. The start is recorded as 2010-04. The registry identifies GE Healthcare as the sponsor. These record details describe the registered study; they do not establish why the study was terminated or whether its planned goals were met. A reason for termination is not reported in the registry record.

Although the title states a non-inferiority objective, the record does not report a non-inferiority margin, the statistical procedure for evaluating that objective, or a comparative analysis. Those details are not reported in the registry record. Nor does the available description establish how management changes were defined or assessed. The design information therefore permits a clear account of the planned imaging order and broad structure, but not a reconstruction of the complete protocol or the analysis intended for the title’s question.

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: Total number of participants enrolled in the study

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: All participants enrolled in study.

6. Primary Endpoint

The registry lists the primary outcome as Completion of CE-BMRI and DE-CEDM, measured over Approximately 8 weeks.

The primary endpoint is “Completion of CE-BMRI and DE-CEDM.” It is defined as the total number of enrolled participants who completed both scan types, with a timeframe of approximately 8 weeks. This is a count endpoint: it describes whether participants completed the two examinations rather than measuring a continuous quantity such as image quality or a time-to-event outcome.

Completion is useful for documenting whether the planned imaging sequence was carried out. In a study requiring participants to undergo both examinations, the count can convey how many enrolled participants reached the point of completing both. It may therefore describe study conduct and the feasibility of obtaining both scans in the planned sequence. The registry’s endpoint definition does not specify a separate threshold for what would constitute successful completion, beyond completion of both examination types.

The registry record does not report the numerical result for this endpoint. Although 224 participants are listed as enrolled, enrollment is not the same as completion of both examinations. It would be incorrect to treat the enrollment count as the number who completed the scans. The completion result is not reported in the registry record.

This endpoint also differs from the question in the official title. Completion alone does not measure whether DE-CEDM and CE-BMRI identified the same management changes, whether either examination led to a change in management, or whether one examination was non-inferior to the other. Those outcomes and their analysis are not reported in the registry record. Thus, the primary endpoint can describe completion of the imaging sequence, but it cannot serve as a substitute for a reported comparative result on management decisions.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a count of participants: those who completed both CE-BMRI and DE-CEDM. This is a binary status at the participant level—completion of both examinations or not—summarized as a count. General statistical explanation: a count endpoint records how many participants meet a defined condition; it does not, by itself, show why other participants did not meet it or how uncertain the count is. The registry gives the endpoint definition and approximate timeframe, but its numerical result is not reported in the registry record.

What does the design imply for comparison?

The record describes a single-group study, with CE-BMRI followed by DE-CEDM in the same participants. It is open-label, with masking recorded as NONE, and allocation recorded as NA. These design features mean the record does not describe random assignment to separate imaging groups or blinded assessment. The examinations have a specified order, so an observed difference could not automatically be attributed to the imaging method alone if the relevant outcomes were reported. General statistical explanation: when a participant receives both procedures, a paired analysis can account for the fact that measurements from the same person are related. Such an analysis requires participant-level paired outcomes and a defined comparison. The registry record does not report that analysis or its results.

The official title states a non-inferiority objective. General statistical explanation: non-inferiority is assessed against a prespecified margin that defines how much worse a new approach could be while still meeting the study’s criterion. A comparative estimate and its uncertainty are needed to judge the result relative to that margin. The non-inferiority margin, comparative estimate, and interval are not reported in the registry record. The listed completion endpoint is not itself a measure of non-inferiority for identifying management changes.

How should uncertainty be understood?

General statistical explanation: a confidence interval expresses the range of effect values compatible with the data under the method’s assumptions. Its width conveys precision: a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The registry record does not report a confidence interval for completion or for a comparison between the examinations. Consequently, the precision of either a completion estimate or a comparative effect cannot be evaluated from the posted results.

General statistical explanation: a p-value is a measure of how incompatible observed data are with a specified null hypothesis under a statistical model; it is not the probability that the null hypothesis is true, and it does not communicate the size or clinical importance of an effect. No p-value for a comparison of management changes is reported in the registry record. A p-value cannot be reconstructed from enrollment alone.

What do the planning assumptions mean?

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is described as computed from an observed effect, with the effect to detect defined as a stated fraction of that observed effect. The record also states that such calculations are planning illustrations, not the trial’s own design. They should not be treated as observed power or as evidence that the study was adequately powered. The registry record does not report a sample-size justification for the trial, and the planning assumptions do not establish that these were the assumptions used to enroll participants.

General statistical explanation: a planning sample size is conditional on assumptions about the effect to detect, the variability or event rate, the significance criterion, and the analysis. It indicates what a design might require under those assumptions; it does not describe the precision actually achieved. An illustration based on a fraction of an observed effect is especially dependent on the effect used as its reference. No specific planning sample-size value is stated in the registry record, so no such value can be interpreted from the record alone.

For time-to-event outcomes, the stated calculation convention is a total number of events; for other outcomes, it is participants per arm. The primary endpoint in this trial is a participant count, not a time-to-event endpoint. General statistical explanation: over-dispersion matters when count variation exceeds the variability assumed by a simple model, and ignoring it can make uncertainty estimates unreliable. The primary outcome is described as a count of participants meeting a completion condition, but no model, dispersion estimate, or variance analysis is reported. There is no basis in the record to infer that an over-dispersion adjustment was used or needed.

Overall, the registry provides a basic endpoint definition and broad design description, but not the inferential methods or estimates needed to assess the comparative objective. The statistical methods for handling paired outcomes, missing observations, or any adjustment are not reported in the registry record. Those omissions prevent a complete assessment of the analysis behind the title’s non-inferiority question.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and zero analyses. It does not identify a hierarchy among the outcomes, describe which outcomes were designated secondary or exploratory, or state how multiple statistical tests were handled. A multiplicity procedure is not reported in the registry record. General statistical explanation: when several outcomes or comparisons are tested, the chance of obtaining at least one apparently notable result can increase unless the analysis plan accounts for the set of tests. Without a reported plan, it is not possible to determine whether multiplicity was addressed or what inferential status to assign to any particular result.

The record does not report how missing outcome data were handled, whether participants who did not complete both scans were excluded from an analysis, or how incomplete examinations were classified. Missing-data methods are not reported in the registry record. General statistical explanation: the meaning of a missing value depends on why it is missing; treating all missing observations alike can produce misleading estimates if the reasons are related to outcomes or participant characteristics. The endpoint is completion of both examinations, so information about incomplete scans would be particularly relevant to understanding that endpoint, but the record does not provide it.

Analysis populations are also not reported. The record does not specify whether analyses were to include all enrolled participants, only those completing both examinations, or another defined group. The statistical analysis populations are not reported in the registry record. This matters because exclusions after enrollment can change the population represented by an estimate and may affect interpretation of a within-participant comparison.

No interim analyses or stopping rules are reported in the registry record. The termination status alone does not reveal whether an interim analysis occurred, why the study ended, or whether the termination related to efficacy, safety, feasibility, or another reason. Those details should not be inferred from the status label.

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.

Most frequent non-serious adverse event terms

The registry lists the group as “CE-BMRI and DE-CEDM Examinations.” For serious adverse events, 224 participants are recorded as at risk and zero as affected. For other adverse events, 224 participants are recorded as at risk and nine as affected. Deaths are recorded as zero. These figures are descriptive registry counts, not estimates from a comparative safety analysis.

The record does not provide the specific terms for the nine other adverse events; the serious-event term list is empty. The timing, severity details beyond the serious-versus-other classification, and attribution of events to either examination are not reported in the registry record. Because participants were described as undergoing both examinations, these group-level counts cannot distinguish events associated with CE-BMRI from events associated with DE-CEDM. Nor does the record report a separate comparison of event rates between examination types.

Zero recorded serious adverse events and zero deaths mean that no such events are counted in this registry entry for the stated group. They do not establish that no events occurred outside the recorded observation or that the examinations have no risk. Likewise, the other adverse event count should not be interpreted as proof of causation. The registry record does not report sufficient detail to assess event type, timing, attribution, or comparative risk.

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

The registry record documents a terminated, open-label, single-group study in which women with newly diagnosed breast cancer were to undergo CE-BMRI followed by DE-CEDM. It lists 224 participants as enrolled and identifies completion of both examinations, within approximately 8 weeks, as the primary endpoint. These registry entries describe the study’s registration and intended imaging sequence.

The record does not report the number who completed both examinations, so the primary endpoint result cannot be determined from the enrollment figure. It also does not report the comparative results needed to assess the title’s question about identifying a change in patient management. No non-inferiority margin, comparative estimate, confidence interval, or analysis result is reported in the registry record. As a result, the posted information does not establish whether the stated non-inferiority objective was met.

The design should not be mistaken for a randomized comparison. The record describes a sequential, within-participant examination plan, not independent randomized groups. If comparative measurements had been reported, their interpretation would depend on the outcome definition, paired analysis, examination order, and handling of missing data. Those details are not reported in the registry record. The title’s crossover wording alone cannot supply the missing analysis.

The safety entry records zero serious adverse events, nine other adverse events, and zero deaths among 224 participants at risk in the listed examination group. These are not separated by examination type, and event terms for the other adverse events are not reported. They therefore do not support a causal or comparative safety conclusion.

The registry record supports a limited account of study conduct and registered outcomes, not an efficacy or non-inferiority conclusion. It also does not state why the study was terminated. No conclusion about the reason for termination or the performance of either examination should be drawn from the termination status or from the absence of posted comparative results.

13. Why This Trial Matters Statistically

This study illustrates why a trial’s stated objective and its registered primary endpoint must be read separately. The official title describes a non-inferiority comparison focused on identifying a change in patient management. The recorded primary endpoint instead counts participants who completed both imaging examinations. Completion is relevant to whether the planned sequence was carried out, but it does not directly quantify management changes or compare the two examinations’ findings.

The design also shows why the word “comparator” requires care. Participants were described as undergoing both examinations in sequence, with CE-BMRI first. That structure differs from randomization to separate groups. A within-participant comparison can be useful when the outcomes are defined and analyzed as paired observations, but the registry does not report such an analysis. The planned sequence alone does not demonstrate equivalence, non-inferiority, or agreement.

For statistical interpretation, an objective such as non-inferiority needs more than a study title. General statistical explanation: the margin, effect estimate, and uncertainty must align with the stated question. Without those elements in the registry record, readers cannot judge whether the data satisfy a non-inferiority criterion, how precise any comparison is, or whether the primary endpoint addresses that criterion.

The record also underscores the difference between enrollment and outcome completion. The enrolled count is stated, while the completion result is not. Treating enrollment as completion would conflate a study-flow quantity with the endpoint itself. In addition, the aggregate adverse-event counts do not identify which examination was associated with an event.

These distinctions matter across clinical research: registered design, endpoint definition, analysis, and reported result are separate parts of the evidence. Here, the registry gives useful context for the intended study, but the absence of endpoint and comparative analysis results limits what can be concluded statistically.

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 available registry information leaves important trial-specific uncertainties. The study is marked terminated, but the reason for termination is not reported in the registry record. It is not possible to infer whether termination followed a recruitment issue, a safety concern, a strategic decision, or another cause. A termination status alone does not indicate the direction or quality of study findings.

The primary endpoint is defined as completion of both examinations, but its numerical result is not reported. The record lists 224 enrolled participants; it does not state how many completed both scans, how many did not, or why any examination might have been incomplete. Participant flow and the handling of missing endpoint information are not reported in the registry record.

The title’s non-inferiority objective is not accompanied by a reported margin or comparative analysis. The record does not describe how a change in management was defined, measured, or compared between imaging methods. It also does not report image interpretation procedures, reader blinding, adjudication, or the timing of management decisions. Those details are not reported in the registry record and should not be assumed.

The sequential design places CE-BMRI before DE-CEDM. The record does not explain whether the interval between examinations varied, how any intervening clinical information was considered, or how order-related effects were addressed in the analysis. The statistical method for the repeated observations is not reported in the registry record. Since allocation is NA and the study is single-group, the record does not provide a randomized control comparison.

Finally, the safety information is aggregate. The specific other adverse event terms, event timing, and attribution to either examination are not reported. The record’s five outcome measures are not accompanied by analyses, and it does not report how multiplicity or analysis populations were handled. These limitations restrict interpretation to the registered design and descriptive counts rather than a comparative evaluation of management impact, diagnostic performance, or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer — NCT01303419.
• Registry record last updated 2019-04-10; status last verified 2019-03.
• Results first posted 2019-04-10.
• 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

The registry describes a multicenter, open-label, single-group study of CE-BMRI followed by DE-CEDM in women with newly diagnosed breast cancer. It lists 224 participants as enrolled, records the study status as terminated, and gives 2010-04 as the start and 2012-06-30 as the primary completion date.

The primary endpoint is the count of participants completing both examinations within approximately 8 weeks. Its numerical result is not reported in the registry record. The record lists five outcome measures and zero analyses. Although the title states a non-inferiority objective related to changes in patient management, a margin and comparative results are not reported.

For the examination group, the registry records zero serious adverse events, nine other adverse events, and zero deaths among 224 participants at risk. The reason for termination, event details, and comparative analyses are not reported in the registry record.