Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer (NCT02810873), a randomized na study. The primary outcome is Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog.

2. Clinical Question

The clinical question is about imaging detection, not treatment benefit. The study concerns diagnostic procedures in patients with breast carcinoma. In the F-18-FDG whole-body scan arm, patients with a positive biopsy and an abnormal F-18-FDG PET whole-body scan were to undergo a whole-body copper Cu 64 TP3805 PET scan. In the arm titled No F-18-FDG Scan, patients with a positive biopsy and no F-18-FDG scan were to undergo breast F-18-FDG PEM followed by breast copper Cu 64 TP3805 PEM.

The registry lists the primary outcome as a lesion count and states that the unit of analysis is the lesion, with potentially multiple lesions available per patient. A secondary outcome concerns the sensitivity of copper Cu 64 TP3805 for detecting primary breast lesions as determined by histology. The record does not report a sensitivity estimate. The posted information therefore supports describing the imaging question and the recorded counts, but not estimating diagnostic accuracy or drawing conclusions about how the imaging compares in clinical use.

3. Trial Design

The registry identifies NCT02810873 as a randomized trial with no masking, while its model classification is single group. It lists two arms with different imaging pathways. These design descriptions do not align neatly: randomization suggests allocation by chance, whereas the arm descriptions assign participants to pathways according to whether an F-18-FDG scan was present. The registry does not explain this apparent tension, so the allocation process cannot be reconstructed from the record.

The study enrolled 19 participants and is marked terminated. The start is recorded as 2008-09 and primary completion as 2012-05. The registry lists breast carcinoma as the condition and includes PET, PEM, Fludeoxyglucose F-18, and Copper Cu 64 TP3805 among the interventions. The trial is not assigned a development phase beyond the registry’s “NA” designation.

In the F-18-FDG Whole-body Scan arm, 6 participants are listed. The description specifies a positive biopsy and abnormal F-18-FDG PET whole-body scan before a whole-body copper Cu 64 TP3805 PET scan. In the No F-18-FDG Scan arm, 13 participants are listed. Its description specifies a positive biopsy, no F-18-FDG scan, an F-18-FDG PEM scan, and then a copper Cu 64 TP3805 PEM scan.

The record does not report the reason for termination, details of the allocation procedure, or a fuller account of the intended design. It also does not report a statistical analysis plan or the rationale for the planned enrollment. Those omissions limit interpretation of how the study was intended to compare imaging pathways.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog, measured over 4 hours after Cu 64 TP3805 administered.

The primary endpoint is the number of F-18-FDG-positive lesions detected by the copper Cu 64 TP3805 analog, assessed 4 hours after Cu 64 TP3805 administration. It is expressed as a count of lesions rather than as a participant-level outcome. The registry notes that a participant could contribute multiple lesions, so the number of lesions and the number of participants are not interchangeable denominators.

Lesion detection is a relevant measure for an imaging study because the purpose of diagnostic imaging is to identify lesions. A count can describe how many lesions were detected in the recorded setting. By itself, however, a count does not show the proportion of all lesions detected, the number of false-positive findings, or how performance varies across participants. Those interpretations require additional information, such as the number and status of lesions assessed and a defined reference standard.

The registry gives values of 10 in the F-18-FDG Whole-body Scan arm and 14 in the No F-18-FDG Scan arm. These are lesion counts; the arm participant counts are 6 and 13. The endpoint description says Cu-64 results will be compared with F-18-FDG results, but the record does not give a statistical comparison or a lesion-level denominator. The secondary outcome concerns sensitivity determined by histology, but its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends first on identifying the unit being analyzed. Here the primary outcome is explicitly a number of lesions, and the registry notes that one participant may contribute multiple lesions. A lesion-level count answers a different question from a participant-level count. It describes lesions recorded as detected, while a participant-level outcome would describe how many people had at least one detected lesion. The posted values should therefore be read as lesion counts, not as participant counts.

What a count can show

A count records the number of events or objects observed within a defined group. To interpret a count as a rate or proportion, a suitable denominator is also needed. For diagnostic detection, that denominator might be the number of lesions known to be present or otherwise eligible for assessment. The registry record does not report such denominators. Consequently, the lesion counts of 10 and 14 do not by themselves indicate what fraction of lesions was detected.

Counts also depend on how observations are grouped and collected. When a participant contributes more than one lesion, those observations may be related: lesions from the same participant share that participant’s clinical and imaging context. A comparison that treats every lesion as if it came from a different participant may understate uncertainty. Appropriate analysis would need to account for the study’s unit of observation and the dependence among lesions. The registry record does not report an analysis addressing multiple lesions per participant.

Comparing imaging pathways

A comparison needs a clearly defined contrast: which groups are being compared, what outcome is measured, and how assignment to groups occurred. The record lists randomized allocation and no masking, but classifies the model as single group. It also describes two pathways whose eligibility differs according to F-18-FDG scan status. Since the registry does not explain the relationship among these features, the comparison structure remains unclear. It would be inappropriate to assume a particular randomization procedure or a common eligibility pathway.

In general, a statistical test assesses how compatible the observed data are with a specified null model. A p-value, when reported, does not measure the size or clinical importance of an effect. A confidence interval gives a range of values compatible with the data and model, and helps communicate precision. Neither a p-value nor a confidence interval is reported for the primary outcome in the registry record. No recalculated comparison is available in the posted results, and there are no reported analyses to interpret.

Why denominators and reference standards matter

Diagnostic measures such as sensitivity require information about the number of affected lesions or cases according to a reference standard, as well as which were detected by the imaging method. The record names histology as the basis for the secondary sensitivity outcome, but does not report the estimate or the underlying counts. Without those results, sensitivity cannot be reconstructed from the primary lesion counts. The primary outcome’s comparison with F-18-FDG is also not enough to establish accuracy against histology.

More generally, diagnostic evaluations distinguish detection of a target condition from false-positive findings and from missed cases. A count of detected lesions alone does not provide all of those components. The record does not report the full lesion-level classification information needed to describe them.

Planning illustrations and observed results

Sample-size planning asks how many participants might be needed under stated assumptions about an effect, variability, significance level, and allocation. Such calculations are planning illustrations, not observed trial findings and not evidence that a study had a particular probability of success. The registry record does not report the trial’s own sample-size justification or a target enrollment rationale. No planning estimate should be treated as the study’s observed power. The recorded arm sizes are enrollment information, not a substitute for a prespecified design justification.

In general, over-dispersion occurs when count outcomes vary more than a simple count model assumes. If present, a model that ignores it can produce uncertainty estimates that are too narrow. Whether over-dispersion was assessed or modeled is not reported in the registry record. The record likewise does not specify a model for counts, a method for handling within-participant clustering, covariate adjustment, or any analysis population.

The appropriate statistical reading is therefore deliberately limited: the posted endpoint values are descriptive lesion counts. No reported inferential analysis establishes a contrast or quantifies its precision, and key details needed to evaluate a lesion-level diagnostic comparison are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the primary lesion-count outcome and a secondary outcome concerning sensitivity for detecting primary breast lesions as determined by histology. It does not report a multiplicity plan describing how inference across outcomes or analyses would be handled. In general, when several statistical questions are tested, the chance of at least one apparently unusual result can increase unless the analysis accounts for the set of tests. No multiplicity-adjusted or unadjusted inferential results are reported, so there is no reported family of tests to evaluate.

Missing-data handling is not reported in the registry record. The record does not describe whether all enrolled participants had evaluable imaging, whether all lesions had a reference-standard assessment, how incomplete scans or unreadable images were treated, or whether any observations were excluded. These details matter because the available results may represent a subset of enrolled participants or lesions if observations are incomplete; the record does not establish whether that occurred.

Analysis populations are also not reported. The record does not say whether analyses were intended to include all enrolled participants, only those who completed the imaging sequence, or another defined group. Although the arm records list 6 and 13 participants, those counts do not establish which participants contributed to each endpoint analysis or how many lesions were assessed.

The registry reports no analyses. As a result, there is no analysis population, missing-data method, or multiplicity procedure to assess from posted inferential results. These omissions prevent a fuller appraisal of whether the reported counts represent a prespecified analysis set and how uncertainty was intended to be handled.

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 safety record lists serious adverse events for 6 participants in the F-18-FDG Whole-body Scan arm and 13 in the No F-18-FDG Scan arm. The number affected by a serious adverse event is 0 in each arm. Deaths are also recorded as 0 in each arm.

For other adverse events, 0 of 6 participants are listed as affected in the F-18-FDG Whole-body Scan arm, and 2 of 13 in the No F-18-FDG Scan arm. These are participant counts, distinct from the primary endpoint’s lesion counts. The record does not list serious adverse-event terms.

Zero recorded serious events means none were reported among the participants represented in these safety counts. It does not prove that an event could not occur, and the record does not provide enough detail to evaluate how completely adverse events were collected or how long participants were followed for safety. The two other adverse-event reports in one arm should be read as counts, not as evidence of a causal relationship with a particular imaging component. The registry record does not report event descriptions or an analysis comparing safety between arms.

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

The posted results establish that the registry contains lesion counts of 10 in the F-18-FDG Whole-body Scan arm and 14 in the No F-18-FDG Scan arm, with 6 and 13 participants listed in those arms. The study’s primary question concerns detection of F-18-FDG-positive lesions by copper Cu 64 TP3805 at 4 hours after administration. These registry entries describe the recorded outcome and the study population sizes.

They do not establish the proportion of eligible lesions detected, because the number of lesions available for detection is not reported. They do not establish participant-level detection rates, since a participant may contribute multiple lesions. They also do not establish sensitivity, specificity, or overall diagnostic accuracy. The secondary sensitivity outcome is named, but its result is not reported in the registry record.

No inferential analysis, confidence interval, or test result is reported for the primary outcome. The recorded counts therefore do not quantify the precision of a difference or support a statistical conclusion that one pathway performed better. The distinct arm descriptions and the registry’s design classifications also leave the comparison structure unclear.

The record is marked terminated, with no termination reason reported. That status does not by itself explain why the trial ended or indicate how the results should be interpreted. The available information is best understood as a limited descriptive record of imaging outcomes and adverse-event counts. It does not establish treatment benefit or harm, and it does not provide a complete basis for judging diagnostic performance.

13. Why This Trial Matters Statistically

This trial is statistically instructive because its primary outcome is a lesion count while enrollment is recorded at the participant level. When participants may contribute multiple lesions, the unit of analysis has direct consequences for interpretation. A lesion total cannot be treated as a participant total, and a valid comparison may need to account for clustering of lesions within participants. The registry record does not report how that issue was handled.

The record also illustrates why outcome labels and denominators matter. “Number of lesions detected” is not equivalent to sensitivity. Sensitivity requires a reference standard and information about the lesions known to be present. Although the registry names histology for its secondary sensitivity outcome, it does not report that result or the counts needed to evaluate it. The posted primary counts consequently offer only a partial view of diagnostic performance.

Another statistical concern is alignment between design and analysis. The registry identifies randomized allocation and a single-group model, and describes two imaging pathways linked to F-18-FDG scan status. Without a fuller account of the design, readers cannot determine how the groups were formed or what comparison was intended. This makes it especially important not to infer causal or comparative conclusions from the arm counts alone.

Finally, the absence of inferential results limits what can be said about uncertainty. Counts can be described, but without a reported analysis and precision estimate, their relationship to the broader patient population remains unclear. The record is a useful example of the difference between having posted outcome values and having enough statistical detail to assess a diagnostic comparison.

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 record contains limited detail for interpreting the imaging results. It does not report the number of eligible lesions, the number of lesions assessed, or the lesion-level classifications needed to evaluate detection against a reference standard. Since multiple lesions may come from one participant, the lack of reported methods for within-participant dependence is a specific limitation for the primary endpoint.

The registry’s design descriptions are difficult to reconcile: allocation is listed as randomized, the model is listed as single group, and the two arm descriptions define different imaging pathways according to F-18-FDG scan status. The record does not explain the allocation process or clarify how those pathways formed the comparison. This uncertainty limits interpretation of any between-arm reading of the counts.

The trial is marked terminated, but the reason is not reported in the registry record. The planned enrollment target and its justification are also not reported. No statistical analysis, confidence interval, or p-value is posted, and the record does not describe handling of missing observations, the analysis population, or multiplicity. The secondary sensitivity result is not reported.

The safety information is also sparse: serious-event counts, other-event counts, and deaths are listed, but event descriptions and a safety analysis are not reported. Follow-up duration for safety is not reported in the registry record. These gaps do not establish that data were missing or that adverse events were incompletely collected; they mean the record does not provide enough detail to assess those possibilities.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer — NCT02810873.
• Registry record last updated 2025-05-04; status last verified 2025-05.
• Results first posted 2018-01-09.
• 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

NCT02810873 is a terminated imaging study in patients with breast cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registry records enrollment of 19 participants, randomized allocation, no masking, and a single-group model. It describes two imaging pathways involving F-18-FDG and copper Cu 64 TP3805 PET or PEM.

The primary outcome is the number of F-18-FDG-positive lesions detected by the copper Cu 64 TP3805 analog, 4 hours after administration. The posted counts are 10 in the F-18-FDG Whole-body Scan arm and 14 in the No F-18-FDG Scan arm. The listed participant counts are 6 and 13. No inferential analyses are reported, and the secondary sensitivity outcome is not reported.

Serious adverse events and deaths are recorded as 0 in both arms; other adverse events are recorded for 0 of 6 and 2 of 13 participants, respectively. The record does not report the reason for termination or the trial’s statistical analysis plan.