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 A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology (NCT01667536), a na phase 2 study. The primary outcome is Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01667536 |
| Phase | Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 105 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Molecular Insight Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Men with high-risk prostate cancer scheduled for radical prostatectomy and extended pelvic lymph node dissection were the intended population. The primary analysis population was defined as subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. The registry says this population was one less than the safety population (n=105); it does not give the primary analysis population’s count directly.
Intervention
The study assessed 99mTc-MIP-1404 imaging after an intravenous injection described as 20 ±3 mCi. SPECT/CT images were to be taken within 3-6 hours of dosing. The registry describes a multicenter, multi-reader, open-label phase 2 study.
Comparator
Histopathology was the truth standard for the imaging analyses. The study also assessed comparative performance against MRI for detecting prostate gland cancer and pelvic lymph node metastases. It was a single-group study, not a randomized comparison between treatment arms; MRI was a secondary diagnostic comparison, not a randomized control group.
Primary question
The primary question was whether MIP-1404 imaging could identify prostate cancer within the prostate gland, measured as subject-level sensitivity against histopathology. The registry specified a 90% confidence interval for the sensitivity measure. It does not report the observed sensitivity estimate or its interval, so the direction and precision of the primary finding cannot be assessed from the registry record.
3. Trial Design
This was a phase 2 diagnostic imaging study in men with high-risk prostate cancer scheduled for radical prostatectomy and extended pelvic lymph node dissection. The registry lists 105 participants in the safety population and describes a single-group design. It does not describe allocation to competing arms: allocation is listed as not applicable. Consequently, the study does not provide a randomized treatment contrast.
Participants received 99mTc-MIP-1404 by intravenous injection, described as 20 ±3 mCi. SPECT/CT imaging was to occur within 3-6 hours after dosing. The study was open-label and involved multiple centers and readers. The record does not report blinding procedures for image readers or other study personnel. Histopathology served as the reference standard for imaging analyses, allowing imaging classifications to be compared with pathology findings.
The primary objective was to assess MIP-1404 sensitivity for detecting cancer within the prostate gland. Secondary objectives addressed detection of metastatic cancer in pelvic lymph nodes, the extent and location of cancer in the prostate, the location of nodal metastases by anatomic region, and comparative performance against MRI for prostate and lymph-node detection. The registry lists 6 outcome measures but reports no analysis estimates. It therefore documents the questions the study set out to address, rather than numerical evidence about how well imaging performed.
The registry marks the study completed and gives enrollment as 105. It does not describe a separate randomized comparator group, and the MRI comparison should not be read as a randomized clinical intervention comparison. The study design can evaluate diagnostic agreement against pathology in the defined study population, but the record alone does not establish how estimates might generalize beyond men scheduled for surgery.
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 | Drug: 99mTc-MIP-1404 |
|---|---|
| STARTED | 105 |
| COMPLETED | 105 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)
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 | Drug: 99mTc-MIP-1404 |
|---|---|---|
| Participants analysed | 105 | |
| Age, Continuous | years | 63.2 (SD 6.8) |
| Gender: Female | Participants | 0 |
| Gender: Male | Participants | 105 |
6. Primary Endpoint
The registry lists the primary outcome as Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland., measured over Within 3-6 hours of dosing SPECT/CT images will be taken.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 90% Confidence Interval |
| Unit | % sensitivity |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is sensitivity for detecting prostate cancer within the prostate gland. Sensitivity expresses the proportion of people with the condition according to the reference standard who are correctly classified as positive by the imaging method. The registry specifies a subject-level measure: the percentages of true-positive subjects correctly identified by the imaging technique. Histopathology results were used as the truth standard for all imaging analyses.
This measure is useful because it addresses whether imaging identifies cancer that pathology confirms. It does not, by itself, describe how often imaging gives a positive result among people without cancer; that question concerns specificity. Nor does sensitivity alone describe the probability that a positive image represents cancer in a particular patient, which depends on the population being assessed and other diagnostic characteristics. These are general properties of diagnostic measures, not reported findings from this study.
The endpoint was planned for assessment within 3-6 hours of dosing, when SPECT/CT images were to be taken. The registry specifies a 90% confidence interval around sensitivity, but does not report the sensitivity estimate, interval limits, or analysis count. Without those results, the endpoint definition can be explained, but the observed diagnostic performance and its precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a diagnostic accuracy study, not a trial comparing the effects of alternative treatments. Its central question concerns whether MIP-1404 imaging detects prostate gland cancer when histopathology is treated as the truth standard. The record defines sensitivity as the percentage of true-positive subjects correctly identified by imaging and specifies a 90% confidence interval. It does not report the observed sensitivity or the interval. There is therefore no numerical primary result to interpret, and no basis in this record for characterizing the imaging result as high, low, or sufficiently precise.
The registry also lists objectives for pelvic lymph node detection, localization of cancer within the prostate, anatomic localization of nodal metastases, and comparisons with MRI. These objectives indicate the range of diagnostic questions considered. They do not establish that any particular comparison favored one imaging method. No analysis estimates are listed, so the registry record does not quantify the findings for these secondary questions either.
The surgical setting matters to interpretation. The primary analysis population required completed MIP-1404 imaging, EPLND, and histopathology. This links imaging classifications to tissue findings, but also defines a selected population of people proceeding through surgery and the specified procedures. The record says this population was one less than the safety population (n=105), without giving a direct count for the primary analysis. Its findings, if reported elsewhere, would need to be understood in relation to this eligibility and analysis definition rather than assumed to apply to all people with prostate cancer.
In general, a confidence interval describes statistical uncertainty around an estimate under the analysis assumptions; it does not reveal the estimate when the estimate and interval limits are absent. The specified 90% interval is a planned reporting feature, not a result by itself. Likewise, a completed study status and an enrollment count do not substitute for outcome estimates. The available record supports description of the design and planned diagnostic questions, but not a conclusion about observed sensitivity, comparative performance, or the certainty of those findings.
The study was open-label and multi-reader. Those features describe the conduct but do not, without further information, establish whether image interpretation was influenced by knowledge of other findings or how reader-level variation was handled. Such details, along with the numerical results and analysis methods, are not reported in the registry record. Interpretation should therefore distinguish what the design intended to measure from what the posted record actually quantifies.
9. Statistical Methods Explained
What does sensitivity measure?
In general, sensitivity is the share of reference-standard positive cases that an index test correctly identifies as positive. Here, the registry defines the primary measure at the subject level and names histopathology as the truth standard. A subject counts as a true positive when the imaging technique identifies prostate gland cancer in a subject whose pathology results establish cancer. This definition describes the target of the statistic; it is not an observed finding. The registry does not state the measured sensitivity or provide the underlying counts needed to reproduce it.
Why use histopathology as the reference?
Diagnostic accuracy requires a reference against which an index test can be assessed. In this study, histopathology findings were designated as the truth standard for imaging analyses. Comparing an image interpretation with pathology makes it possible to classify imaging results as agreeing or disagreeing with the reference. In general, the value of such an assessment depends on how the reference results are obtained and how they are linked to each participant’s images. The registry identifies the reference standard and the required procedures for the primary analysis population, but does not provide further detail on specimen assessment, adjudication, or handling of discordant interpretations.
What does the confidence interval add?
In general, a confidence interval represents uncertainty around an estimate arising from sampling variability under the specified statistical procedure. A point estimate alone would not convey how much precision the data support; the interval provides a range of values compatible with the estimation procedure. The registry planned a 90% confidence interval for the primary sensitivity measure. Neither the estimate nor the interval bounds are reported, so its width and the precision of the result cannot be evaluated. The confidence level does not itself say whether the study met a target or whether the imaging result was clinically adequate.
How should multiple readers be considered?
The registry describes the study as multi-reader. In general, multiple readers can reveal how diagnostic performance varies across interpreters, rather than relying on a single reader’s classifications. However, estimates from multiple readers may require methods that account for related readings on the same participants and for differences among readers. The registry record does not report the reader-level analysis approach, whether readings were independent, or how reader variation entered the primary estimate. No particular statistical model or pooling method should be inferred.
What do the secondary diagnostic questions add?
The secondary objectives broadened assessment beyond prostate gland sensitivity. They addressed pelvic lymph node metastasis detection, extent and location of disease within the prostate, anatomic location of nodal metastases, and comparison with MRI for both prostate and pelvic node detection. In general, these outcomes can describe different aspects of diagnostic performance, but they answer distinct questions and may use different units or analysis populations. The registry lists 6 outcome measures and no analysis estimates. It does not give enough numerical results to assess any secondary diagnostic measure or MRI comparison.
What can planning illustrations establish?
In general, sample-size planning illustrations describe the participant counts that would be needed under chosen assumptions for a specified statistical objective. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. These are explicitly planning illustrations, not the study’s own design justification. The study itself is listed as single-group, so an equal-allocation two-arm illustration should not be mistaken for the trial’s allocation scheme. Such planning figures are not observed power and do not establish whether the study was adequately designed. The underlying observed effect and numerical illustrations are not reported in the registry record.
More generally, an analysis plan would specify the estimator, confidence interval procedure, handling of incomplete or indeterminate imaging, and any adjustments for reader or center effects. The registry record does not report those details. The absence of a reported method does not establish that a method was not used; it means that the record does not allow readers to verify it. Statistical explanations of these concepts are general and should not be taken as a description of procedures used in this study unless the registry explicitly states them.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 6 outcome measures spanning prostate detection, lymph-node detection and localization, and comparisons with MRI. Evaluating multiple outcomes can create a multiplicity issue: in general, the more statistical questions examined, the greater the chance that at least one apparently notable finding arises by chance if no adjustment or hierarchy is used. The registry record does not report a multiplicity strategy, a hierarchy among secondary endpoints, or whether any analyses were considered exploratory. No adjustment method should be assumed.
The primary analysis population was defined as subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. The registry says this group was one less than the safety population (n=105), but does not report the group’s count directly or explain why a participant was not included. The record does not describe how missing images, missing pathology, uninterpretable scans, or other incomplete data were handled. It also does not report whether any imputation or sensitivity analyses were used.
In general, restricting an analysis to participants with all required data can affect how well an estimate represents the enrolled population, especially if completion or data availability is related to disease or test performance. That is a general consideration, not evidence that a particular bias occurred in this study. The record does not provide enough information to judge the impact of exclusions or missing information on the diagnostic estimates.
The registry reports no analysis estimates. It therefore does not show whether outcome-specific denominators differed or how uncertainty was calculated for each endpoint. Details of multiplicity handling, missing-data procedures, and analysis populations beyond the primary definition are not reported in the registry record.
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 |
|---|---|---|---|
| Drug: 99mTc-MIP-1404 | 0 | 105 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Drug: 99mTc-MIP-1404 | 0 of 105 |
The safety listing gives 105 participants at risk in the 99mTc-MIP-1404 group. It records 0 participants affected by serious adverse events and 0 affected by other adverse events in that listing. These are the figures recorded for the specified group; they should not be expanded into a claim that no events of any kind occurred or that all possible harms were ruled out.
The death field is null rather than a numerical count. The number of deaths is therefore not reported in the registry record. A null entry should not be read as zero. The record also does not provide serious-event terms, event descriptions, severity details, or information about how long participants were followed for safety reporting. The list of top serious-event terms is empty, which does not add detail beyond the posted serious-event count.
In general, adverse-event counts depend on definitions, observation periods, reporting completeness, and the population assessed. A zero in a registry count means that no affected participants are recorded for that category in that entry; it does not establish that the underlying risk is absent. The safety figures should be read as registry reporting, separate from the diagnostic accuracy question.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase 2, open-label, multicenter, multi-reader study assessed 99mTc-MIP-1404 imaging in men with high-risk prostate cancer scheduled for radical prostatectomy and extended pelvic lymph node dissection. It defines a primary diagnostic question, specifies histopathology as the reference standard, and lists related secondary questions about disease detection and comparison with MRI. These registry entries describe the study’s purpose and structure.
The record does not establish the observed diagnostic performance. Although the primary measure is sensitivity with a 90% confidence interval, neither the estimate nor the interval is reported. There are no reported analysis estimates for the secondary outcomes. Consequently, the record cannot establish how accurately the imaging identified prostate gland cancer, whether it detected pelvic lymph-node metastases, how it compared with MRI, or how precise any such estimates were.
The study is not a randomized comparison of treatments. Its single-group design and diagnostic focus do not support conclusions about comparative treatment effects. Histopathology is the named truth standard for image assessment, not a treatment comparator. The inclusion of MRI comparisons among the objectives also does not, by itself, show that MRI or MIP-1404 performed better.
In general, diagnostic measures apply most directly to the population and procedures used to obtain them. The defined primary analysis population required completed imaging, EPLND, and histopathology, so any estimate would need to be interpreted in that context. The record does not provide enough information to assess how representative that group was of people outside the surgical setting.
The safety listing records 0 participants affected by serious adverse events and 0 affected by other adverse events, with 105 at risk; deaths are not reported in the registry record. These entries are limited safety reporting, not proof that every possible adverse outcome was absent. Overall, the posted record supports a description of the planned diagnostic assessment and selected safety counts, but not a conclusion about imaging performance or clinical benefit.
13. Why This Trial Matters Statistically
Diagnostic studies depend on more than an image and a disease label. They require a clearly defined target population, an index test, a reference standard, a unit of analysis, and transparent handling of incomplete or ambiguous observations. This study’s registry record makes several of those elements explicit: men with high-risk prostate cancer scheduled for surgery, MIP-1404 SPECT/CT imaging, histopathology as the truth standard, and subject-level sensitivity for the primary prostate gland question.
The record also illustrates why design descriptions and numerical results must be separated. A completed phase 2 study and a defined confidence interval do not tell readers what sensitivity was observed or how precisely it was estimated. With no analysis estimates reported, the diagnostic questions remain documented but unanswered numerically in this record. That distinction is important when interpreting registries: planned endpoints are not findings, and a stated statistical measure is not a result.
The multi-reader and MRI-comparison objectives raise further statistical questions. In general, observations from different readers may be related, while several endpoints may create multiplicity considerations. Understanding those issues requires the analysis methods and outcome estimates, which are not reported in the registry record. Clear reporting of denominators, uncertainty, missing data, and reader handling would help readers evaluate the strength and limits of diagnostic evidence.
The study’s surgical population is also a statistical consideration. Results from participants proceeding to prostatectomy and EPLND would be tied to that setting and the specified analysis requirements. Diagnostic performance can vary across populations and clinical pathways, so generalization requires evidence beyond the study description alone. The registry record gives a useful framework for identifying the questions that matter, while leaving the central quantitative evidence unavailable.
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 study from the registry record is the absence of numerical outcome estimates. The primary sensitivity measure and its specified 90% confidence interval are not reported, and no analyses are listed. Without estimates, interval limits, or underlying counts, the primary diagnostic finding cannot be quantified. The record also gives no numerical results for the secondary questions or the planned MRI comparisons.
The study population is defined through a surgical pathway: participants in the primary analysis had to complete MIP-1404 imaging, undergo EPLND, and have histopathology results. The registry says this population was one less than the safety population (n=105), but does not directly state the analysis count or explain the difference. It does not describe whether incomplete imaging, missing pathology, or uninterpretable findings occurred or how such cases were handled.
The registry describes the study as open-label and multi-reader but does not report reader blinding, reader-level methods, adjudication procedures, or the statistical approach to center and reader variation. It does not explain how the multiple outcomes were prioritized or whether multiplicity was addressed. Those omissions limit assessment of analytic robustness; they do not establish that the study lacked procedures not recorded in the registry.
The MRI objectives are comparative diagnostic assessments within a single-group study, not randomized comparisons of treatments. The registry does not provide enough detail to characterize the MRI comparison methods or results. The listed safety counts likewise lack event descriptions and follow-up duration, and deaths are not reported in the registry record. Together, these gaps restrict conclusions to the design, endpoint definitions, and the safety counts that are explicitly recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology — NCT01667536.
- Registry record last updated 2017-02-07; status last verified 2016-12.
- Results first posted 2016-03-30.
- 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
NCT01667536 is a completed phase 2, single-group, open-label, multicenter, multi-reader study of 99mTc-MIP-1404 imaging in men with high-risk prostate cancer scheduled for radical prostatectomy and extended pelvic lymph node dissection. The registry lists enrollment of 105 and an intravenous dose described as 20 ±3 mCi. SPECT/CT images were to be taken within 3-6 hours of dosing.
The primary objective was subject-level sensitivity for detecting prostate gland cancer, with histopathology as the truth standard and a specified 90% confidence interval. Secondary objectives included pelvic lymph-node detection and localization, prostate extent and location, and comparisons with MRI. The registry lists 6 outcome measures but no analysis estimates, so the diagnostic findings and their precision are not reported in the registry record.
The safety listing records 0 participants affected by serious adverse events and 0 affected by other adverse events among 105 at risk. Deaths are not reported in the registry record.