Gynecological Sentinel Lymph Nodes CEUS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Gynecological Sentinel Lymph Nodes CEUS (NCT05105087), a na early/phase 1 study. The primary outcome is Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT).

2. Clinical Question

This is a diagnostic detection question: it concerns identification and counting of sentinel lymph nodes, rather than a comparison of cancer treatment outcomes. The registry also lists secondary outcomes concerning node location, size, depth beneath the skin surface, and metastatic deposits. It does not report numerical findings for those outcomes in the record. The clinical question therefore has a clear diagnostic focus, but the registry information alone does not establish how the two detection approaches compared in the analyzed participants.

3. Trial Design

The study, titled “Gynecological Sentinel Lymph Nodes CEUS,” is registered as NCT05105087. It is classified as EARLY PHASE1 and has a single-group model. Allocation is listed as NA, and masking is listed as NONE. The record states that the study is completed, with a start date of 2022-04-28 and a primary completion date of 2023-11-15. Thomas Jefferson University is listed as the sponsor.

The diagnostic group received perflubutane microbubble injections subdermally and underwent ultrasound before standard-of-care cancer treatment. The described ultrasound procedure lasted 30 minutes. The study intended to compare sentinel lymph node detection by contrast-enhanced ultrasound with detection under standard care, described as blue dye or PET-CT. Because standard care varies depending on cancer treatment, the reference procedure was not necessarily the same for every participant.

The registry reports enrollment of 9. For the primary outcome, it says that only participants who completed CEUS and surgery were analyzed, with N=5. The record does not explain why the primary-outcome analysis population differs from the enrollment figure, or describe the status of participants not included in that analysis. The outcome description does not report a randomized assignment or a separate control group. The registry’s own note cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison.

The registry lists five outcome measures, including the primary sentinel-node count and secondary measures of location, size, depth, and metastatic deposits. It lists no analysis entries. The protocol’s statistical plan, sample-size justification, interim analyses, and detailed analysis procedures are not reported in the registry record. Planning illustrations associated with the posted results should not be interpreted as the study’s original design or as observed power.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Screening assessments were performed within 4 weeks prior to the administration of Sonazoid. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history were recorded. 9 participants received CEUS. 5 completed both CEUS and surgery with pathology and were analyzed. 2 were ineligible for surgery (advanced disease), and 2 withdrew consent prior to surgery; thus no outcome data were available for these 4 participants.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only participants who completed CEUS and surgery (N=5) were analyzed.

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 Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT), measured over up to 30 minutes during CEUS procedure.

The primary endpoint is the number of sentinel lymph nodes identified by lymphosonography, compared with the number identified by standard care. The registry describes standard care as blue dye or PET-CT. The unit is sentinel lymph nodes, and the stated timeframe is up to 30 minutes during the CEUS procedure.

A count endpoint records how many nodes are detected, rather than measuring a continuous quantity such as size or depth. In general, comparing detection counts can describe whether diagnostic approaches identify similar or different numbers of nodes. It does not, by itself, establish whether every detected node is a true sentinel node, whether any node was missed, or how accurate either procedure is against an independent reference standard. Those questions require additional information about verification and classification.

The registry lists the count comparison as the primary outcome and lists node location, size, depth beneath the skin surface, and metastatic deposits as secondary outcomes. The primary outcome population is limited to participants who completed CEUS and surgery, reported as N=5. Numerical counts and a numerical comparison are not reported in the registry record. Without those results, the endpoint definition can be described, but the direction, magnitude, and precision of the observed comparison cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count: the number of sentinel lymph nodes identified using contrast-enhanced ultrasound, considered alongside the number identified by standard care. Counts describe how many events or items were observed. They are not continuous measurements, and their analysis may require methods that reflect the distributional features of count data. The registry does not report the numerical count results or the statistical method used to compare them.

Why can count data require special care?

In general, a simple count model may assume that the variability in the data follows a particular relationship with the average count. Over-dispersion means that the observed variability is greater than the model expects. If over-dispersion is present and not accommodated, uncertainty estimates may be too small and tests may appear more decisive than warranted. Whether over-dispersion was assessed or addressed in this study is not reported in the registry record.

The outcome is described as a comparison of counts from CEUS and standard care. In general, when two measurements come from the same participant, the analysis should account for their within-participant relationship rather than treat them as independent observations. The registry does not describe the participant-level data structure or the method used to analyze the comparison. It also does not specify how data from participants whose standard-care detection used different procedures were handled.

What does a confidence interval add?

In general, a confidence interval communicates uncertainty around an estimated effect or difference. A narrow interval indicates greater precision under the chosen model and assumptions; a wide interval indicates less precision. An interval can also show which values remain compatible with the data and analysis. The registry does not report a confidence interval for the primary endpoint, so the precision of the comparison cannot be evaluated from the record.

A p-value, in general, describes how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the analysis assumptions were true. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a difference. No primary-outcome p-value is reported in the registry record. The record lists 0 analysis entries, so it does not provide an inferential analysis to interpret.

How should the planning illustrations be understood?

The planning illustrations are described as calculations based on the observed effect, not as the trial’s own design. Their stated assumptions include 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. For time-to-event outcomes, the planning method uses a total number of events; for other outcomes, it gives participants per arm. These are planning illustrations, not observed power and not evidence that the original study was designed with those assumptions. The registry does not report the trial’s own sample-size justification.

In general, a planning sample size depends on the effect targeted, variability assumptions, significance level, desired power, and analysis method. A calculation based on an observed effect is especially dependent on that effect estimate: if the estimate is imprecise, the planning illustration inherits that uncertainty. The registry record does not provide the primary numerical result needed to evaluate an observed-effect planning calculation. No planning illustration should be read as a substitute for a reported trial result.

What does the analysis population tell the reader?

The primary outcome description states that only participants who completed CEUS and surgery were analyzed, with N=5. In general, restricting an analysis to participants with completed procedures can affect interpretation if completion is related to the outcome or to participant characteristics. The registry does not report reasons for non-completion, describe missing outcome data, or state whether any sensitivity analyses were performed. It therefore does not allow an assessment of how the analysis population may affect the estimate.

These general statistical principles explain what would be useful for interpreting a count comparison: the actual counts, a clearly specified comparison method, an uncertainty estimate, and a description of how the analysis population and reference procedures were handled. Those details are not reported in the registry record. The available information defines the diagnostic question and reports the analysis population, but not the statistical evidence needed to quantify the comparison.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures: the primary count of sentinel lymph nodes identified by lymphosonography and standard care, and secondary outcomes concerning node location, size, depth beneath the skin surface, and metastatic deposits. When multiple outcomes are examined, general statistical practice considers whether the chance of finding an apparently notable result across the collection of analyses has been addressed. The registry does not report a multiplicity strategy or identify which secondary outcomes were analyzed.

The registry lists 0 analysis entries. Numerical results for the primary and secondary outcomes, and any corresponding inferential analyses, are not reported in the registry record. A protocol-defined hierarchy, adjustment procedure, or distinction between confirmatory and exploratory analyses is also not reported in the registry record. In the absence of such information, the listed outcomes should not be treated as evidence that each was tested or that any finding was prespecified.

The primary outcome population is described as participants who completed CEUS and surgery, with N=5. The registry does not report why other enrolled participants are not in that primary analysis population, whether any outcome data were missing, or how missing data were handled. In general, missingness can affect interpretation when the likelihood of having an observed outcome is related to the outcome itself or to factors that also influence it. The record does not provide information that would establish whether such concerns apply.

The registry also does not report an intention-to-diagnose approach, a sensitivity analysis for missing observations, or a comparison between participants included and not included in the primary analysis. These omissions limit assessment of the analysis population, but they do not show that a particular bias occurred. The available record identifies the analyzed group and the listed outcomes without explaining the handling of missing data or multiplicity.

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 reports safety information for the diagnostic group, titled “Diagnostic (Perflutane Microbubble, Ultrasound)” in the adverse-event listing. It records 9 participants at risk for serious adverse events and 0 affected, 9 at risk for other adverse events and 0 affected, and 0 deaths. No top serious adverse-event terms are listed.

These figures are counts as recorded, not a complete description of the safety profile. The record does not report event definitions, monitoring procedures, the duration of safety follow-up, or whether the adverse-event counts cover all periods of participation. It also does not provide further detail about how safety information was collected or reviewed.

Zero recorded events should be read as zero events listed in this registry record, not as proof that an event is impossible or that the procedure has no risk. The safety information is specific to this study and its recorded participants. It does not establish how frequently adverse events might occur in another group or setting. No percentage or rate is calculated from the posted counts.

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

This study addresses whether contrast-enhanced ultrasound can identify sentinel lymph nodes in patients with lower genital tract cancers, with the detection count compared against standard care. Its design and endpoint make it a diagnostic detection study, not a randomized evaluation of cancer treatment. The registry describes CEUS with perflubutane microbubbles and ultrasound, and identifies blue dye or PET-CT as the standard-care reference procedures.

The record does not report the numerical primary outcome. Consequently, it does not show whether CEUS identified more, fewer, or the same number of sentinel lymph nodes as the standard-care procedure in the analyzed participants. It also does not provide an estimate of the size of any difference or its precision. The absence of these results is not evidence that the methods were equivalent, nor is it evidence that one method performed better.

The primary analysis population is reported as N=5 participants who completed CEUS and surgery, while the enrollment figure is 9. The record does not explain the difference or provide enough information to determine how the analysis population relates to all enrolled participants. It also does not report participant-level results or details about which standard-care reference procedure was used for each participant.

The record lists secondary outcomes for node location, size, depth beneath the skin surface, and metastatic deposits, but does not report their numerical findings. It also does not provide an inferential analysis, confidence interval, or p-value for the primary comparison. Thus, the registry information defines what was intended to be measured but does not permit a quantitative judgment about comparative detection performance.

The safety counts are similarly limited: the registry lists no serious adverse events, other adverse events, or deaths in the diagnostic group. Those counts describe the recorded study experience; they do not establish the absence of risk beyond that record. The appropriate conclusion is therefore bounded: the study’s diagnostic question and basic design are documented, while comparative outcome results and their uncertainty are not reported in the registry record.

13. Why This Trial Matters Statistically

The study is statistically notable because its central endpoint is a count comparison in a single-group diagnostic study. The registry describes CEUS detection alongside detection by standard care, but also states that the standard-care procedure varies depending on cancer treatment. This makes the definition and handling of the reference measurement important to interpretation. The record does not describe those details at the participant level.

The analysis population also matters. The registry reports enrollment of 9 and says that the primary outcome was analyzed only among participants who completed CEUS and surgery, with N=5. The reason for this analysis population is not reported. In a small diagnostic study, clear reporting of participant flow and completed procedures is important for understanding what observations contribute to the comparison and how broadly the results may apply.

Count outcomes can require attention to distributional assumptions and to the relationship between paired measurements. General statistical methods for counts may need to account for over-dispersion, and paired measurements should not automatically be treated as independent. The registry does not state which methods were used or report an uncertainty estimate. Because no numerical primary result is reported, readers cannot assess the observed comparison or its precision.

The record lists multiple secondary outcomes but no analysis entries. Without results and information about the analysis plan, it is not possible to assess whether multiplicity was considered or which findings, if any, were intended as confirmatory. Planning illustrations based on an observed effect are a separate exercise; they are not observed power and do not replace results or the study’s own design justification.

These issues do not establish that the study was biased or that its intended comparison is uninformative. They identify what statistical reporting is needed to understand the evidence: the detection counts, the method of comparison, an uncertainty estimate, the handling of the different reference procedures, and an explanation of the analysis population.

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 registry record does not report numerical results for the primary endpoint or secondary outcomes. It therefore does not allow the comparative detection counts, the direction or size of a difference, or the precision of an estimate to be assessed. No p-value or confidence interval for the primary comparison is reported.

The study is a single-group, non-randomized comparison, with allocation listed as NA and masking as NONE. The registry itself notes that this is not a randomized comparison and that arms are not a like-for-like control comparison. Standard care is described as blue dye or PET-CT and varies depending on cancer treatment; the record does not specify how this variation was handled analytically.

The primary-outcome description limits analysis to participants who completed CEUS and surgery, with N=5, while enrollment is reported as 9. Reasons for the difference, the status of participants not included in the primary analysis, and missing-data handling are not reported in the registry record. The record also does not describe the analysis method, uncertainty estimates, multiplicity procedures, or the trial’s sample-size justification.

These limitations concern what can be interpreted from the registry record. They do not establish that the procedures were performed incorrectly or that the results would be biased. They mean that the comparative outcome evidence and several details needed to judge its reliability are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Gynecological Sentinel Lymph Nodes CEUS — NCT05105087.
• Registry record last updated 2025-08-22; status last verified 2025-08.
• Results first posted 2025-08-22.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05105087, “Gynecological Sentinel Lymph Nodes CEUS,” is a completed EARLY PHASE1, single-group study sponsored by Thomas Jefferson University. The registry lists enrollment of 9 and dates of 2022-04-28 for study start and 2023-11-15 for primary completion. The diagnostic intervention combined subdermal perflubutane microbubble injections with contrast-enhanced ultrasound before standard-of-care cancer treatment.

The primary endpoint compared sentinel lymph node counts identified by lymphosonography with counts identified by blue dye or PET-CT, up to 30 minutes during the CEUS procedure. The primary outcome description reports an analysis population of participants who completed CEUS and surgery, N=5. Numerical primary and secondary outcome results are not reported in the registry record, and the record lists 0 analysis entries.

The adverse-event listing reports 0 serious adverse events, 0 other adverse events, and 0 deaths. The registry does not report the trial’s statistical plan, sample-size justification, missing-data procedures, or reasons for the primary analysis population.