Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors (NCT02609737), a na na study. The primary outcome is Overall Response Rate (ORR).

2. Clinical Question

The clinical question combines imaging and treatment aims. The brief summary says the study aims to assess whether the experimental drug is safe to use for imaging and to treat neuroendocrine tumors in the later study steps. Those aims do not amount to a controlled comparison: the record lists one study group and no randomized allocation. It therefore describes an investigation of experience within the enrolled group, not a head-to-head estimate against another treatment.

The planned primary outcome is Overall Response Rate (ORR), counted as participants and assessed according to RECIST 1.1. The stated timeframe is 2 years. The outcome description also says median progression-free and overall survival will be estimated and reported with 95% confidence intervals. However, the record lists only one outcome measure, and it does not give values for ORR, progression-free survival, or overall survival. Whether the stated survival estimates were ultimately produced is not reported in the registry record.

3. Trial Design

The registry lists a single-group study with enrollment of 20 participants and a completed status. It lists no masking and gives allocation as NA. The study is titled around theranostics of 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in patients with neuroendocrine tumors. Its interventions include PET/CT imaging, 68Ga-DOTA-JR11, and 177Lu-DOTA-JR11.

The brief summary describes three steps and says not everyone will have all three steps. It states that the overall goals are to assess safety for imaging and treatment. The listed arm is “68Ga-DOTA-JR11 and 177Lu-DOTA-JR11.” Its description includes PET/CT with approximately 150-200 MBq of 68Ga-DOTA-JR11 and a statement about interpreting lesions with focal radiotracer uptake not explained by physiologic sstr2 expression as metastatic disease. The remaining arm description is incomplete in the registry record, so its further decision criteria cannot be characterized from that text.

The record gives a start date of 2015-11-13 and a primary completion date of 2020-12-10. It does not report the number of participants who completed each study step or the number included in the primary outcome analysis. The status is recorded as completed, but completion status alone does not provide an outcome estimate or establish that every planned measurement was reported.

Because the study is single-group and does not list a comparator, its design cannot directly estimate a treatment contrast between groups. The registry record does not report a protocol-level sample-size justification, randomization procedure, or further detail on the analysis population. Those design features should not be inferred from the enrollment target or from the outcome description.

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 Overall Response Rate (ORR), measured over 2 years.

Overall Response Rate (ORR) is the listed primary outcome. It is expressed as a count of participants, and the description says response is assessed according to RECIST 1.1. In general, an overall response outcome summarizes whether participants meet defined criteria for tumor response over a specified assessment period. The registry names the criteria but does not report the response count or explain in detail how assessments were scheduled, confirmed, or handled when a participant had no evaluable assessment.

The timeframe is 2 years. This defines the stated period associated with the outcome, but the record does not clarify whether it means response at a specific visit, response observed at any assessment during that period, or another operational definition. That detail is not reported in the registry record.

Response rate is used in clinical research because it describes the proportion or count of participants meeting a response definition, rather than describing changes for an individual participant. Here, however, the outcome is recorded as a count, and no response count or rate is posted. Without those results, the magnitude and precision of the observed ORR cannot be assessed.

The outcome description also refers to estimating median progression-free and overall survival with 95% confidence intervals. These are time-to-event measures, distinct from ORR. The registry record does not report their estimates, confidence intervals, event definitions, or censoring details.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary outcome measure?

The listed primary outcome is Overall Response Rate (ORR), counted as participants and assessed according to RECIST 1.1. The stated timeframe is 2 years. A binary outcome classifies each participant according to whether an event or criterion is met. For response, the relevant classification would depend on the prespecified response definition and assessment rules. The registry identifies RECIST 1.1 but does not report the detailed operational rules, such as how missing or unevaluable assessments were classified. It also does not post the number meeting the response criteria.

In general, a participant count is a direct way to present how many people experienced an outcome. A rate or proportion can additionally relate that count to a defined analysis population. Those quantities are interpretable only when the denominator and analysis population are clear. The registry record does not report the primary-outcome denominator or an ORR estimate, so neither can be reconstructed from the enrollment figure alone.

How should uncertainty be understood?

The outcome description says median progression-free and overall survival will be estimated and reported with 95% confidence intervals. In general, a confidence interval gives a range of values compatible with the observed data under the statistical method used. It reflects sampling uncertainty under that method and its assumptions; it does not guarantee that the range contains the true value, and it does not address every source of bias. No survival estimates or confidence intervals are reported in the registry record.

For a binary outcome such as response, uncertainty depends on the observed number of participants meeting the criterion and the number included in the analysis. For time-to-event outcomes, uncertainty also depends on event and censoring information. These are general statistical considerations, not statements about analyses conducted in this study. The registry lists zero analyses and supplies no event-level or participant-level results from which to examine those details.

What does the single-group design allow?

In general, a single-group study can describe outcomes and safety observations among people receiving the study interventions. It does not create a randomized control group for estimating a between-group treatment effect. The registry gives allocation as NA and identifies the model as single-group. No like-for-like comparison is available in this record. Consequently, the reported design would not support attributing differences against an external or historical group unless such a comparison were separately specified and justified; no such analysis is reported.

The intervention list includes PET/CT imaging, 68Ga-DOTA-JR11, and 177Lu-DOTA-JR11. The summary says the study has three steps and that not everyone will complete all three. This means the group’s exposure and assessment experience may not be identical for every participant, but the record does not report step-specific participant counts or outcomes. The details needed to describe a step-specific analysis are not reported in the registry record.

What can be inferred from the safety counts?

Safety summaries commonly distinguish serious events from other adverse events. A participant count records how many people were affected, while an event count may count repeated occurrences in the same person. The registry uses participant language for the primary outcome and lists safety counts with 20 at risk, but it does not provide detailed event-level data, severity grading beyond the serious classification, timing, or attribution. The serious and other adverse event counts should therefore be read as posted group summaries, not as a complete description of each event or its cause.

Over-dispersion is a general issue for count outcomes when variability exceeds what a simple probability model expects. It can affect standard errors and confidence intervals if the model does not accommodate the extra variability. That concept is not evidence that over-dispersion occurred in this trial: the primary endpoint is recorded as a participant count, and no statistical model or analysis is reported. There is no basis in the registry record to assess whether over-dispersion was relevant to any analysis.

What analysis details are absent?

The registry record does not report a sample-size justification, a prespecified statistical analysis plan, interim analyses, or the handling of missing data. It also does not report a confidence interval or hypothesis test for ORR. These omissions prevent readers from checking whether the stated outcome was analyzed according to a prespecified method, whether all enrolled participants were included, or how uncertainty was quantified. The absence of such details in the record does not establish that no methods were used; it means they are not reported in the registry record.

General planning calculations based on an observed effect are not observed power and should not be interpreted as evidence about the study’s design adequacy. No observed ORR effect is posted, and no numerical planning results are reported in the record analyzed. Thus no study-specific sample-size or power conclusion can be drawn. Statistical interpretation should remain focused on what is documented: a single-group design, a planned response outcome, and safety counts, without a posted efficacy analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, ORR, with a timeframe of 2 years. Its description also says median progression-free and overall survival will be estimated and reported with 95% confidence intervals. The record does not explain whether these survival measures were secondary outcomes, how they related to the primary outcome, or whether any formal hypothesis tests were planned. A multiplicity strategy is not reported in the registry record.

In general, multiplicity arises when several outcomes, comparisons, or repeated tests are considered. Testing many questions can increase the chance of obtaining an apparently notable result by chance unless the analysis plan accounts for the testing structure. Estimation with confidence intervals is also affected by multiple analyses when readers interpret intervals collectively. These are general considerations; the registry does not establish that formal testing was conducted for this study.

Missing-data methods and analysis populations are not reported. The study summary says that not everyone will have all three steps, but it does not give step-specific completion counts or explain how participants without an assessment were handled for ORR. The record also does not state whether the primary analysis was based on all enrolled participants, participants who received an intervention, or participants with evaluable tumor assessments. These distinctions matter because the denominator can change the meaning of an outcome count.

In general, missingness can affect interpretation when the likelihood of an unavailable measurement is related to participants’ health, treatment exposure, or outcome. The registry record does not provide enough information to characterize missingness or assess its consequences. The absence of a reported method should not be replaced by assumptions about imputation, exclusion, or follow-up procedures.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: platelet count decreased (30.0%), lymphocyte count decreased (25.0%), neutrophil count decreased (15.0%), white blood cell decreased (15.0%), esophageal varices hemorrhage (10.0%).

The safety summary lists 20 participants at risk, 7 with serious adverse events, 13 with other adverse events, and 11 deaths for the group named 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11. These counts are descriptive. The registry record does not specify the timing of the events, whether participants could contribute to more than one category, or the relationship of individual events to either intervention.

The listed serious adverse-event terms include platelet count decreased (30.0%), lymphocyte count decreased (25.0%), neutrophil count decreased (15.0%), white blood cell decreased (15.0%), esophageal varices hemorrhage (10.0%), and anemia (5.0%). These percentages are reported as posted; their definitions, event-counting rules, and detailed denominators are not described in the record. They should not be treated as comparative risks because there is no control group listed.

The 11 deaths are recorded in the safety summary. The registry record does not report their causes, timing, or attribution to study interventions. A death count alone does not establish that an intervention caused a death, nor does the record allow a comparative safety conclusion. The counts summarize what is listed; they do not replace participant-level safety context.

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

The record documents a completed, single-group study of radiolabeled somatostatin antagonists in patients with neuroendocrine tumors. It identifies imaging and treatment aims, lists an ORR endpoint assessed according to RECIST 1.1, and reports selected safety counts. These registry entries describe the study’s scope and some observations recorded for safety.

The primary response result is not reported in the registry record. There is no posted ORR count, rate, or confidence interval. The outcome description mentions median progression-free and overall survival estimates with 95% confidence intervals, but those estimates are also not reported. Therefore, the record does not quantify the observed antitumor response or survival outcomes, and it does not show how precise any such estimates would be.

The design is single-group, not a randomized comparison. Even if an outcome estimate were available, a single-group result would describe participants in that group and would not by itself establish how outcomes compare with another treatment. In general, causal interpretation requires a design and analysis that address alternative explanations for observed outcomes. The registry does not report a comparative analysis.

The safety counts should be interpreted separately from efficacy. The serious and other adverse event counts and the listed event percentages are descriptive entries. The record does not establish that a particular event or death was caused by study intervention. It also does not provide timing or participant-level context sufficient for a fuller safety analysis.

The most defensible reading is limited: the registry describes the intended questions and design, and it records a set of safety observations, but it does not provide the primary efficacy result or the survival estimates named in the outcome description. No conclusion about treatment benefit, comparative effectiveness, or causal safety can be drawn from these registry entries alone.

13. Why This Trial Matters Statistically

This study illustrates a key statistical distinction between a planned outcome and a reported result. The registry identifies ORR as the primary outcome and gives its assessment framework and timeframe. Yet without a response count, analysis denominator, or uncertainty estimate, readers cannot quantify what the study observed. Naming an endpoint is not equivalent to reporting its estimate.

Its single-group design also makes the target of inference important. A within-group outcome can describe what was recorded among participants, but it does not supply the counterfactual comparison needed to estimate what would have happened under another treatment. This is a general limitation of uncontrolled designs, especially when the research question concerns treatment effects rather than feasibility or description.

The record further shows why safety counts require careful interpretation. Counts and event percentages can be informative descriptions, but without event timing, attribution, and a comparator, they cannot distinguish intervention-related events from other causes or establish relative risk. The deaths listed in the safety summary likewise cannot be assigned a cause based on the count alone.

Finally, the study description says not all participants will complete all three steps. That makes transparent reporting of participant flow and outcome-specific analysis populations especially relevant. Those details are not reported in the registry record. The statistical lesson is not that missing details prove a flaw in conduct; rather, readers need them to judge denominator choices, uncertainty, and the reach of any conclusion. Here, the available record supports a description of design and selected safety observations, but not an efficacy estimate.

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 statistical interpretation is that the registry record does not report the primary outcome result. It names ORR, RECIST 1.1, and a timeframe of 2 years, but gives no response count, analysis denominator, estimate, or confidence interval. The survival estimates mentioned in the outcome description are likewise absent.

The study has a single-group design and no listed randomized comparator. This prevents a direct controlled estimate of differences in outcomes. The enrollment is 20, but the record does not report how many participants completed each of the three study steps or contributed an evaluable outcome. Enrollment cannot be assumed to equal the primary analysis population.

The arm description is incomplete in the registry record. It begins to describe PET/CT imaging and interpretation of radiotracer uptake, but the text ends before its further criteria are complete. The record also does not report detailed assessment schedules, response confirmation rules, missing-data procedures, or a statistical analysis plan. These omissions limit assessment of how the stated endpoint would be operationalized and analyzed.

For safety, the registry gives counts and selected serious adverse-event terms, but does not report event timing, detailed severity, attribution, or causes of death. These constraints mean the counts cannot establish causal relationships or comparative safety. The record’s completed status does not resolve these reporting gaps, and the absent details should not be replaced with assumptions.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors — NCT02609737.
• Registry record last updated 2022-02-01; status last verified 2020-12.
• Results first posted 2022-02-01.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes a completed, single-group study of 68Ga-DOTA-JR11 imaging and 177Lu-DOTA-JR11 in patients with neuroendocrine tumors. Enrollment is 20; allocation is listed as NA, masking as none, and the study has three steps that not everyone will complete.

ORR according to RECIST 1.1 is the listed primary outcome, with a timeframe of 2 years. The description also refers to median progression-free and overall survival estimates with 95% confidence intervals. None of these outcome results are reported in the registry record.

The safety summary lists 7 participants with serious adverse events, 13 with other adverse events, and 11 deaths among 20 at risk. Event attribution and causes of death are not reported. The design and posted counts can be described, but the absent outcome estimates prevent a statistical assessment of response or survival.