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 PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer (NCT01737619), a na na study. The primary outcome is False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01737619 |
| Phase | NA |
| Condition | Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 101 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with high-risk endometrial cancer. The listed conditions include endometrial clear cell, mixed, serous, and grade 3 endometrioid adenocarcinomas, as well as malignant mixed mesodermal (Mullerian) tumor.
Intervention
Patients undergo PET/CT before surgery and intraoperative lymph node mapping using indocyanine green solution. The registry describes the mapping injections as superficial and deep cervical injections during full lymphadenectomy.
Comparator
The diagnostic approaches of interest are PET/CT and sentinel lymph node mapping. The record describes a single-group study, not randomized arms or a separate like-for-like control group. Both procedures are part of the study approach.
Primary question
The stated primary endpoint concerns the false negative rate of PET/CT versus sentinel lymph node mapping for detecting positive lymph nodes. The registry record does not report the observed rates, their uncertainty, or the analysis used to compare them.
The clinical question is whether these diagnostic procedures identify lymph node involvement in patients undergoing surgical staging for high-risk endometrial cancer. The record frames the work as a prospective evaluation at the time of surgical staging, with PET/CT performed before surgery and mapping performed during surgery.
This is a diagnostic-evaluation question, not a randomized treatment-effect question. The registry does not describe an allocation process or a separate control arm. It also does not report an endpoint result, so the relative false-negative performance of the approaches cannot be determined from the posted results.
3. Trial Design
The registry describes a prospective, single-group study of PET/CT and lymph node mapping in patients with high-risk endometrial cancer. The listed allocation is NA, and the masking field is NONE. The record does not describe random assignment or a blinded assessment process. It lists an enrollment of 101 and a status of active, not recruiting.
In the described study approach, patients undergo PET/CT before surgery. During surgery, they undergo lymph node mapping with indocyanine green solution, alongside full lymphadenectomy. The listed procedures and interventions also include computed tomography, positron emission tomography, laboratory biomarker analysis, and lymphadenectomy. The record does not explain how each listed intervention contributes to the endpoint analysis.
The trial is not a comparison of separate randomized groups. Rather, the stated primary question contrasts two diagnostic approaches in the context of the study’s surgical staging procedures. The registry’s skip note likewise identifies that the record is not a randomized comparison and that its arms should not be treated as a like-for-like control comparison.
The listed start date is 2013-04-03, and the listed primary completion date is 2025-04-30. The registry status is active, not recruiting. A primary endpoint result, the final analysis date, and a statistical analysis plan are not reported in the registry record. The record lists three outcome measures and zero analyses.
These design details describe the setting and procedures, but they do not establish how the diagnostic results were classified or compared. Details such as the reference standard for positive lymph nodes, the handling of inconclusive tests, and the analysis population are not reported in the registry record.
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 | Sentinel Node Mapping |
|---|---|
| STARTED | 101 |
| COMPLETED | 101 |
| 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 | Sentinel Node Mapping |
|---|---|---|
| Participants analysed | 101 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 64 |
| Age, Categorical: >=65 years | Participants | 37 |
| Age, Continuous | years | 62 (29 to 86) |
| Sex: Female, Male: Female | Participants | 101 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 22 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 60 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 19 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 15 |
| Race (NIH/OMB): White | Participants | 63 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 19 |
| Region of Enrollment: United States | participants | 101 |
6. Primary Endpoint
The registry lists the primary outcome as False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers., measured over 36 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled as the false negative rate of PET/CT versus sentinel lymph node mapping in detecting positive lymph nodes in women with high-risk endometrial cancer. Its unit is listed as a percentage, and its timeframe is 36 months. The record does not report a measured percentage or explain the endpoint’s operational definition.
In general, a false negative occurs when a diagnostic test gives a negative result for a person who does have the condition the test is intended to detect. A false negative rate describes the frequency of those misses among people who have the condition, under the study’s chosen definitions and reference standard. It is useful in diagnostic evaluation because it focuses on missed disease rather than on all test classifications combined.
The endpoint is intended to address how often each approach misses positive lymph nodes. The exact reference standard used to establish nodal status, the denominator for each rate, and the rules for classifying test results are not reported in the registry record. Without those details and the observed results, the endpoint cannot be independently interpreted or compared from the record alone.
A false negative rate is not the same measure as a false negative predictive value. In general, the latter describes the frequency of disease among test-negative results. The registry lists false negative predictive values among its secondary outcomes, but does not report their results or definitions.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a diagnostic question but does not post the primary endpoint result. It therefore does not show an observed false negative rate for PET/CT or for sentinel lymph node mapping, and it does not report a statistical comparison between them. No conclusion about which approach missed fewer positive lymph nodes can be drawn from the posted results.
The record lists three outcome measures and zero analyses. Although it describes the primary endpoint and secondary outcomes, it does not include an analysis estimate, confidence interval, p-value, or other measure of statistical uncertainty. It also does not report the number of participants contributing data to the primary endpoint. These omissions prevent an assessment of the precision or completeness of any diagnostic comparison.
The status is active, not recruiting, and the registry lists a primary completion date of 2025-04-30. Those administrative fields do not substitute for endpoint data. They do not establish that every planned assessment or analysis has been completed, and the registry record does not explain the status of results reporting.
Interpretation also depends on how positive lymph node status was established and how equivocal or missing test results were handled. Such details are not reported in the registry record. In general, diagnostic performance estimates can change with the reference standard, the definition of a positive result, and which participants are included. The record does not give enough information to evaluate those choices.
The study includes both PET/CT before surgery and intraoperative mapping during full lymphadenectomy. That description indicates the diagnostic procedures under evaluation, but it is not itself evidence of their diagnostic performance. The presence of a surgical procedure in the study description does not establish which assessment served as the reference standard for the primary endpoint.
The record’s single-group design matters when interpreting the comparison. It does not describe randomization to separate diagnostic strategies or a conventional control arm. The primary question can still concern diagnostic performance, but the registry information does not establish the comparison method, whether assessments were analyzed as paired observations, or how uncertainty in a difference was estimated.
Accordingly, the posted record supports a description of the study question, setting, and procedures, not a result-based judgment about diagnostic accuracy. The absence of posted estimates is not evidence that the tests had identical performance, nor is it evidence that either test had a particular false-negative rate. The findings are not reported in the registry record.
9. Statistical Methods Explained
The registry describes diagnostic procedures and a false negative rate endpoint, but it does not report an analysis plan or statistical estimates. The concepts below are general explanations of how such measures are usually understood; they do not describe methods confirmed for this study.
What does a false negative rate describe?
In general, a false negative is a negative test classification in a case where the reference standard indicates that the condition is present. A false negative rate focuses on missed cases among cases with the condition. Its interpretation depends on how the study defines a positive reference-standard result and how it handles uncertain classifications. Those operational details are not reported in the registry record.
A false negative rate differs from sensitivity, although the two are closely related: sensitivity describes the share of cases with the condition that a test correctly identifies as positive, while the false negative rate describes the share it classifies as negative. These definitions are general. The registry record does not report a sensitivity estimate or specify whether it calculated one.
How is a false negative predictive value different?
In general, a false negative predictive value concerns test-negative results: it describes how often disease is present among those results. This differs from the false negative rate, which begins with cases known to have the condition and asks how often the test misses them. The registry lists false negative predictive values as a secondary outcome, but reports no estimate or calculation method.
Why does the reference standard matter?
A diagnostic performance measure requires a basis for deciding which cases truly have the condition. In general, changing that reference standard or its classification rules can change the resulting rate. The study description includes full lymphadenectomy and surgical staging, but the registry does not state exactly how these procedures were used to determine positive lymph node status for the endpoint. It also does not report how incomplete, indeterminate, or unavailable results were treated.
What does a confidence interval add?
In general, a confidence interval expresses the statistical uncertainty around an estimate. A narrow interval indicates greater precision under the analysis assumptions; a wide interval indicates less precision. An interval can help readers judge whether the data are compatible with a range of underlying values. No confidence interval or endpoint estimate is reported in the registry record, so the precision of the proposed diagnostic measures cannot be assessed.
What can be inferred from a comparison?
When two diagnostic procedures are assessed in the same participants, their results may be paired. In general, an analysis that accounts for this pairing can use the within-participant relationship between test results. The registry describes both PET/CT and mapping in the study approach, but does not state whether both results were available for each participant, whether the analysis treated them as paired, or what comparison method was used.
A diagnostic comparison also needs a clear target. Comparing rates requires definitions of the relevant numerator and denominator for each method, and a statistical contrast requires a method for quantifying uncertainty in the contrast. The registry does not report these definitions or methods. The endpoint title alone does not establish whether the comparison was based on a difference, a model, or another procedure.
What do the planning assumptions mean?
The record includes a description of sample-size planning illustrations based on the observed effect. Those illustrations are described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. The description also distinguishes total events for time-to-event planning from participants per arm for other planning calculations.
These are planning illustrations, not observed power and not a description of the trial’s own design. In particular, the trial is described as single-group, whereas the illustration refers to equal allocation between two arms. The record does not report that these assumptions were used to design or analyze this study. No sample-size justification or trial-specific statistical plan is reported in the registry record.
The general concepts above explain the kinds of information needed to interpret diagnostic performance. They cannot fill in the missing endpoint result, reference-standard definition, analysis population, or analysis method for this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and secondary outcomes, including false negative rates and false negative predictive values for lymphatic spread, as well as mortality and complications related to lymph node dissection. It also lists three outcome measures and zero analyses. The record does not explain how the outcomes were organized or whether additional analyses were planned.
When a study evaluates multiple outcomes or makes multiple comparisons, multiplicity can affect how statistical evidence is interpreted. In general, a statistical plan may specify whether and how to account for multiple tests. Such a plan, including any adjustment or hierarchy among outcomes, is not reported in the registry record. No p-values or estimates are posted for assessing that issue.
The registry does not describe missing-data procedures, rules for excluding participants from an analysis, or analysis populations for the primary endpoint. It does not say how incomplete imaging, mapping, or reference-standard information would be handled. These matters can affect which observations contribute to a diagnostic estimate and how representative the analyzed data are.
Interim analyses and stopping rules are not reported in the registry record. Their absence from the record should not be interpreted as confirmation that they were or were not used. Without these details, the posted information does not support a detailed assessment of selective reporting, missingness, or the multiplicity of statistical tests.
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 |
|---|---|---|---|
| Sentinel Node Mapping | 0 | 101 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sentinel Node Mapping | 0 of 101 |
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 |
|---|---|
| Sentinel Node Mapping | 0 of 101 |
The registry lists a Sentinel Node Mapping group with 101 at risk for serious adverse events and 0 affected. It also lists 101 at risk for other adverse events and 0 affected, with 0 deaths. These are the safety figures recorded for the group; the registry does not provide event terms in its serious-event list.
Zero recorded events means that no events in those categories are listed as affecting participants in the registry entry. It does not establish that no event occurred outside the reporting definitions or observation period, and it does not by itself show that the study procedures have no risks. The record does not describe the adverse-event collection window, severity criteria for other events, or completeness of safety follow-up.
The safety entries should also be read separately from the diagnostic endpoint. They do not indicate whether PET/CT or mapping correctly identified positive lymph nodes. The registry does not report a safety comparison with another group, and the study is not described as a randomized comparison. No causal comparison of safety outcomes is available in the posted record.
12. What the Result Does, and Does Not, Mean
The record establishes that the study evaluates PET/CT and sentinel lymph node mapping in surgical staging for high-risk endometrial cancer. It describes PET/CT before surgery and mapping with indocyanine green during surgery alongside full lymphadenectomy. It also identifies a primary diagnostic question focused on false negative rates.
However, the registry does not report the primary endpoint result, the secondary outcome results, or statistical analyses. The record therefore does not show how often either approach missed positive lymph nodes, how precise any estimate was, or whether any difference was compatible with chance variation. It cannot establish which diagnostic approach performed better.
The result also cannot be interpreted as a treatment effect. The study is described as single-group, with no randomized allocation or separate control arm. The central question concerns diagnostic performance, not whether a treatment changes a clinical outcome. Mortality and complications are listed as secondary outcomes, but their results are not reported apart from the safety counts recorded for the mapping group.
Even with endpoint results, interpretation would depend on the reference standard, analysis population, handling of missing or indeterminate findings, and statistical methods. These details are not reported in the registry record. The primary endpoint’s 36 months timeframe is listed, but the record does not explain the timing rules or how that timeframe applies to diagnostic assessments.
The appropriate reading is therefore limited: the registry describes the planned clinical question and procedures, and it records the stated safety counts, but it does not provide the diagnostic results needed to answer the primary question. Missing results should not be treated as evidence for or against either approach.
13. Why This Trial Matters Statistically
This study raises a statistical question about diagnostic misses rather than a conventional comparison of treatment outcomes. False negative rates focus on cases with positive lymph node status and ask whether the diagnostic procedure classified them as negative. That focus makes the definition of positive status and the reference standard central to interpretation.
The study description places PET/CT and intraoperative lymph node mapping within the same surgical-staging context. In general, evaluating multiple diagnostic approaches in the same setting can raise questions about paired measurements, missing test results, and how the reference standard is applied. The registry record does not report how these questions were addressed, so readers cannot assess whether the planned comparison used methods suited to the data structure.
The single-group design is also important. The record does not describe randomized diagnostic strategies or a like-for-like control group. This does not prevent a diagnostic evaluation, but it means the study should not be read as a randomized trial of competing treatments. The analysis must be understood through its diagnostic definitions and comparison methods, which are not reported.
Finally, reporting matters as much as the endpoint label. Without estimates and uncertainty intervals, readers cannot assess the magnitude or precision of diagnostic performance. The record identifies a relevant clinical question but does not post the results needed to answer it 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 main limitation for interpreting this record is the absence of reported diagnostic results. The primary false negative rate endpoint is identified, but no rate, comparison estimate, confidence interval, or statistical test is reported. The registry lists zero analyses.
The endpoint definition is not sufficiently detailed in the registry record to establish its exact numerator, denominator, or reference standard. Although full lymphadenectomy is described as part of the study approach, the record does not specify how lymph node status was confirmed for analysis, how discordant assessments were treated, or how indeterminate findings were classified.
The single-group design does not provide a randomized control comparison. The record describes both diagnostic procedures in the study approach, but does not state whether each participant completed both assessments or whether all procedures were available for every endpoint analysis. Missing-data rules and analysis populations are not reported.
The registry lists the status as active, not recruiting and gives a primary completion date of 2025-04-30, but does not report whether final data collection or analysis is complete. Multiplicity procedures, interim analyses, stopping rules, and a trial-specific statistical plan are not reported in the registry record.
Safety interpretation is also limited by absent details about event definitions, collection periods, and follow-up completeness. The recorded zero counts should be read as the registry entries, not as proof that risks are absent. Overall, the record supports description of the design and question, but not a complete appraisal of the diagnostic or safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer — NCT01737619.
- Registry record last updated 2026-10-08; status last verified 2026-10.
- Results first posted 2025-11-28.
- 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
NCT01737619 is a prospective, single-group evaluation of PET/CT and lymph node mapping in patients with high-risk endometrial cancer. The registry lists an enrollment of 101, a start date of 2013-04-03, a primary completion date of 2025-04-30, and a status of active, not recruiting.
Patients are described as undergoing PET/CT before surgery and intraoperative lymph node mapping with indocyanine green during full lymphadenectomy. The primary endpoint concerns the false negative rate of PET/CT versus sentinel lymph node mapping, with a listed timeframe of 36 months.
The record lists three outcome measures and zero analyses. It does not report diagnostic endpoint results, confidence intervals, or a statistical analysis plan. The safety entry records 0 serious adverse events, 0 other adverse events, and 0 deaths in the Sentinel Node Mapping group.