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 Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI (NCT04097535), a registered phase not stated study. The primary outcome is Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04097535 |
| Phase | Phase not stated |
| Condition | Glioma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Imperial College London |
| Results posted | Yes |
2. Clinical Question
Population
People with a suspected cerebral glioma on standard of care MRI were the population described for the safety results. The study enrolled 11 participants; its stated aim refers to 10 evaluable patients. The registry record does not give further eligibility details or describe the characteristics of the enrolled participants.
Intervention
The study used PET/MRI with [18F]-FPIA to quantify tracer uptake in gliomas. The registered intervention is PET/MRI. The record describes the measurement as standardised uptake values on [18F]-FPIA PET/MRI, with a primary measure named SUV60 max.
Comparator
No randomized comparison is described. Allocation is not stated, and the listed arms are not a like-for-like control comparison. The study therefore should not be read as a treatment comparison between separate groups. Any contrast by tumour grade or type would be an association question, not a randomized estimate of an intervention effect.
Primary question
The primary question was how much [18F]-FPIA uptake could be measured in human gliomas. The investigators also hypothesised that uptake would be higher in high-grade than lower-grade gliomas, consistent with their proposed relationship between tumour grade and early fatty acid oxidation. The registry record does not report the observed uptake or a statistical test of that hypothesis.
3. Trial Design
This was a completed study sponsored by Imperial College London, registered as NCT04097535. The registry record gives the study title as “Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI” and its official title as “Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Glioma Using 18F-FPIA.” The listed condition is glioma, and the registered intervention is PET/MRI.
The study started on 2018-12-06 and has a primary completion date of 2020-08-07. Enrollment is listed as 11. The brief summary describes an aim to quantify early-step fatty acid oxidation in 10 evaluable patients using 18F-FPIA PET/MRI. The record does not explain the difference between the enrollment figure and the evaluable-patient figure, or describe the disposition of participants.
This is not described as a randomized trial. Allocation is not stated, and the registry record explicitly cautions that the arms are not a like-for-like control comparison. The design is therefore best understood as a measurement study, with an additional stated hypothesis about the relationship between uptake and glioma grade. The record also lists a secondary outcome relating uptake to tumour type, histological grade, MGMT, and IDH gene expression. It does not describe a treatment assignment or a control intervention.
The primary outcome is quantitative [18F]-FPIA uptake, expressed as SUV60 max, with mean as the reported parameter and full range as the dispersion measure. Its timeframe is listed as -21-0 days. The registry record does not report a statistical analysis plan, sample-size justification, interim analyses, or analysis results. It lists two outcome measures and zero analyses.
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 | Patients With a Suspected Cerebral Glioma on Standard of Care MRI |
|---|---|
| STARTED | 11 |
| COMPLETED | 10 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Patients With a Suspected Cerebral Glioma on Standard of Care MRI |
|---|---|
| [18F]FPIA/radiotracer production failure - Participant subsequently withdrew consent. | 1 |
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 | Patients With a Suspected Cerebral Glioma on Standard of Care MRI |
|---|---|---|
| Participants analysed | 10 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 5 |
| Age, Continuous | years | 59.7 (31 to 78) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 6 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas, measured over -21-0 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | SUV60_max |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas.” It measures standardised uptake values on [18F]-FPIA PET/MRI. The specified unit is SUV60 max, the summary parameter is the mean, and the dispersion is described as the full range. The timeframe is recorded as -21-0 days.
In general, a quantitative imaging endpoint can describe the magnitude of a tracer signal in the target tissue. A mean gives a central summary of the measured values, while the full range describes the span from the lowest to the highest recorded value. These summaries answer different questions: a mean alone does not show how widely individual measurements vary, and a range alone does not show where measurements tend to lie.
The endpoint is relevant to the stated research aim because the study sought to quantify uptake associated with early steps of fatty acid oxidation in gliomas. The investigators proposed that uptake might differ by glioma grade. Uptake is the registered imaging measure; it should not be treated as a direct result about clinical outcomes or as proof of a biological mechanism. The registry record does not report the numerical endpoint result, the range endpoints, or details of how the measure was calculated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the question and planned measurement, but it does not report the primary uptake result. It therefore does not establish the observed magnitude or spread of [18F]-FPIA SUV60 max in the studied gliomas. The mean and full-range values are not reported in the registry record, nor are statistical estimates or tests for the primary endpoint. The listed count of zero analyses reinforces that no analysis results are displayed in the registry record.
The investigators’ hypothesis was that uptake would be higher in high-grade gliomas than in lower-grade gliomas. This is a hypothesis stated in the brief summary, not a finding. No grade-specific uptake values, estimated contrast, confidence interval, or test result are reported. Without those results, the proposed association cannot be judged for direction, size, or precision from the registry record. The secondary outcome concerning tumour type, histological grade, MGMT, and IDH gene expression likewise has no reported result.
The study enrolled 11 participants, while the stated aim refers to 10 evaluable patients. These figures describe enrollment and the intended evaluable group; they do not show how many participants contributed data to each analysis. The registry record does not explain the difference or report an analysis population. It would therefore be inappropriate to assume that every enrolled participant had an evaluable scan or contributed to the primary measure.
General statistical interpretation depends on both the estimate and its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data under the analysis assumptions; it is not itself a guarantee that the true value lies in that interval. No confidence interval is reported for this study’s uptake measure. Similarly, a p-value would address compatibility with a specified null model, but no p-value or corresponding analysis is reported. Statistical significance, precision, and clinical importance cannot be inferred from the study aim or enrollment count.
The record contains planning assumptions for illustrative sample-size calculations based on an observed effect, but no resulting planning counts are stated in the registry record described for this trial. Such illustrations are not observed power and do not substitute for the study’s results. In particular, the registry record does not report an effect estimate from which readers could assess how those planning scenarios relate to the measured uptake. The reported information supports a description of the study’s purpose and registered outcomes, not a conclusion about whether the hypothesis was supported.
9. Statistical Methods Explained
The registered outcome and the available analysis information need to be read separately. An endpoint tells readers what the study intended to measure; it does not, by itself, show the measured result or how that result was analysed. For this study, the endpoint is quantitative [18F]-FPIA uptake on PET/MRI, specified as SUV60 max and summarised by a mean with full range. The registry record does not report the resulting values or an analysis of them.
What does a mean describe?
In general, the arithmetic mean is a measure of the centre of a set of observations. It combines all measured values into a single summary. This can be useful when the research question concerns average uptake, but a mean does not reveal whether observations cluster closely or differ substantially. It can also be influenced by unusually high or low measurements. The registry record specifies a mean for the primary endpoint but does not report the individual measurements or the resulting mean.
Why report the full range?
In general, the full range states the lowest and highest observed values. It conveys the outer span of the data, but does not show how observations are distributed between those endpoints. A range can be sensitive to an extreme observation, so it is most informative when considered alongside the sample size and other summaries. Here, the registered dispersion is the full range, but its endpoints are not reported in the registry record. No additional distribution summaries are reported.
What does SUV60 max mean in this record?
The registry identifies SUV60 max as the unit or measure for the primary outcome and describes the outcome as standardised uptake values on [18F]-FPIA PET/MRI. It does not define the calculation, specify image-processing details, or explain how measurements from participants or tumour regions were combined. Those methodological details are not reported in the registry record, so a more specific interpretation of the metric would go beyond the registered description.
How should the grade hypothesis be assessed?
The brief summary states a directional hypothesis: FPIA uptake would be higher in high-grade gliomas than in lower-grade gliomas. In general, evaluating such a hypothesis requires the relevant uptake observations by grade and a defined comparison method. An estimated difference or other contrast would describe the magnitude and direction of the association; an uncertainty interval would indicate how precisely that estimate is supported. A statistical test can address compatibility with a specified null hypothesis, but it does not by itself establish the size or importance of an association. The registry record reports none of these grade-specific estimates or tests.
The distinction between association and causal effect matters. Grade is a tumour characteristic, not a randomized assignment in this record. Even if uptake differed between grade groups, that pattern would describe an association in the observed data. It would not show that grade caused the uptake difference, or that changing a treatment would change uptake. No randomized comparison is reported, and the registry record cautions that the arms are not a like-for-like control comparison.
What do the sample-size assumptions represent?
The registry describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s actual design. The record says the study is not a randomized comparison and does not state allocation. A planning illustration under equal allocation therefore should not be mistaken for the structure of the enrolled study.
General sample-size calculations ask how much information a hypothetical design would need under stated assumptions. The answer depends on the target effect, variability, significance criterion, power target, and analysis approach. A calculation based on a fraction of an observed effect is conditional on that effect estimate and should be interpreted as a planning scenario, not as evidence that the study had a particular probability of finding a result. It is not observed power. No sample-size justification for the actual study is reported in the registry record.
The registry’s general note distinguishes time-to-event illustrations, which report total events, from other illustrations, which report participants per arm. This distinction is useful when reading planning outputs, because event counts and participant counts are not interchangeable. It does not turn the present measurement study into a two-arm comparison. The actual planning counts are not reported in the registry record.
Finally, statistical interpretation requires a clear account of the analysis population, handling of missing observations, and prespecified analysis choices. Those details are not reported in the registry record. Without outcome values, uncertainty measures, and an analysis description, readers can identify the measurement question and hypothesis but cannot reconstruct or evaluate a statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary quantitative uptake measure and a secondary outcome concerning the correlation of 18F-FPIA uptake with tumour type and histological grade, including MGMT and IDH gene expression. The record does not report how many separate tests or contrasts were planned for these outcomes, whether any adjustment for multiple comparisons was intended, or how the primary and secondary questions were ordered in analysis. A multiplicity strategy is not reported in the registry record.
In general, testing multiple hypotheses can increase the chance that at least one result appears notable by chance. Adjustment methods can address that issue, but their relevance depends on the planned family of tests and inferential goals. Since the specific analyses and results are not reported, it is not possible to assess the impact of multiplicity or determine whether any adjustment was used.
The record gives enrollment as 11 and describes 10 evaluable patients in the study aim. It does not report participant-level outcome availability, reasons for any missing measurements, or the handling of missing data. The number contributing to the primary endpoint or secondary correlations is therefore not reported in the registry record.
Analysis populations are also not described. The registry does not state whether analyses used all enrolled participants, only participants with evaluable scans, or another defined group. It does not report a statistical analysis plan, imputation method, or sensitivity analysis. These omissions limit assessment of selection and missing-data effects. They do not establish that data were missing or that a particular method was used; the relevant details are simply 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 |
|---|---|---|---|
| Patients With a Suspected Cerebral Glioma on Standard of Care MRI | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Patients With a Suspected Cerebral Glioma on Standard of Care MRI | 0 of 10 |
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 |
|---|---|
| Patients With a Suspected Cerebral Glioma on Standard of Care MRI | 0 of 10 |
The safety results list a group titled “Patients With a Suspected Cerebral Glioma on Standard of Care MRI,” with 10 participants at risk for serious adverse events and 0 affected. The same group has 10 participants at risk for other adverse events and 0 affected, and deaths are listed as 0. No top serious adverse-event terms are listed.
These are registry counts for the reported group. They do not supply information about how adverse events were defined, how long participants were followed for safety, how events were collected, or whether all participants were assessed in the same way. Those details are not reported in the registry record. The safety group count of 10 should not automatically be taken to represent every enrolled participant, since enrollment is listed as 11 and the stated evaluable group is 10.
In general, a count of zero recorded events means that no events are listed for that category in the reported data; it does not prove that an event is impossible or establish the safety profile beyond the observed and recorded experience. The registry figures should be read as descriptive counts, not as a comparative safety estimate. No control comparison is described, and the record does not report a comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed study set out to quantify [18F]-FPIA uptake in human gliomas using PET/MRI. It also records the investigators’ hypothesis that uptake would be higher in high-grade than lower-grade gliomas, and a secondary question about relationships with tumour type, histological grade, MGMT, and IDH gene expression. These are the research questions and proposed interpretation, not findings.
The record does not report the primary uptake values, the full range, grade-specific results, correlation estimates, confidence intervals, p-values, or statistical analyses. Consequently, it does not permit a conclusion about the magnitude or precision of uptake, whether the grade hypothesis was supported, or whether uptake was associated with the listed tumour characteristics. The absence of reported results should not be interpreted as evidence of no difference or no association.
Even if a difference in uptake by grade were reported elsewhere, the design information in this record would support interpretation as an observed association rather than a causal effect. No randomized comparator is described; allocation is not stated, and the arms are not a like-for-like control comparison. A measurement association would not by itself establish a biological mechanism or demonstrate an effect on patient outcomes.
The enrollment figure is 11, while the aim refers to 10 evaluable patients. The registry does not clarify the participant flow or analysis population. That uncertainty, together with the lack of reported outcome estimates and methods, limits how precisely the study can be interpreted from this record. The listed zero adverse-event counts are likewise descriptive and do not establish safety beyond the reported group and the information recorded.
In short, the registry identifies a focused imaging measurement study and its biological hypothesis. It does not provide the result needed to judge that hypothesis. No treatment conclusion or clinical recommendation follows from the information reported in the registry record.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between measuring a biological signal and testing a clinical intervention. Its primary question concerns the magnitude of [18F]-FPIA uptake in gliomas, while the grade-related hypothesis concerns whether that signal varies with tumour characteristics. Those questions call for clear definitions of the measurement, the analysis population, and the comparison being made.
Reporting a mean together with the full range can help readers consider both a central value and the span of observations. Yet summaries cannot replace the underlying result and its uncertainty. In this record, the endpoint is described but its numerical values are not reported. That gap prevents readers from evaluating the observed signal, its variability, and the precision of any estimated relationship.
The study also illustrates why hypotheses must be distinguished from results. A proposed higher uptake in high-grade gliomas is a testable expectation, not evidence that the pattern occurred. If such comparisons are made across tumour types, grade categories, and gene-expression characteristics, the analysis plan and multiplicity approach matter for interpretation. Neither is reported in the registry record.
Finally, the enrollment and evaluable-patient figures raise a reporting question about the analysis population. Transparent participant flow and missing-data handling would help readers understand which observations support each estimate. Together, these issues show why statistical transparency matters even for a study centered on measurement: readers need estimates, uncertainty, analysis details, and a clear account of who contributed data to judge what the evidence supports.
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 most immediate limitation in interpreting this trial from the registry record is that the primary measurement result is not reported. The record names the endpoint and its summaries, but gives no mean uptake value or full-range endpoints. It also gives no grade-specific values, association estimates, or uncertainty measures. The stated hypothesis therefore cannot be evaluated from the reported results.
The registry does not describe the statistical analysis plan, analysis population, participant flow, or handling of missing measurements. Although enrollment is listed as 11 and the aim refers to 10 evaluable patients, the record does not explain the difference. The number of participants contributing to each outcome is not reported in the registry record.
Measurement procedures are also incompletely described in the available information. The endpoint is identified as SUV60 max on [18F]-FPIA PET/MRI, but the calculation and image-processing details are not reported. The timeframe is listed as -21-0 days, without further explanation in the record.
The study is not described as a randomized comparison, and allocation is not stated. The record cautions that arms are not a like-for-like control comparison. Accordingly, the design information does not support a treatment-effect interpretation. The stated relationship between uptake and tumour grade would be an association question, and the registry does not report its analysis.
Safety results are limited to the recorded counts for the listed group. Definitions, collection procedures, and the safety follow-up period are not reported. These limits do not establish that the study lacked procedures or analyses; they mean those details cannot be assessed from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI — NCT04097535.
- Registry record last updated 2024-11-21; status last verified 2024-09.
- Results first posted 2024-11-21.
- 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
NCT04097535 is a completed study sponsored by Imperial College London, with glioma listed as its condition and PET/MRI as its intervention. It started on 2018-12-06, has a primary completion date of 2020-08-07, and lists enrollment of 11. Its stated aim refers to 10 evaluable patients.
The primary outcome measures quantitative [18F]-FPIA uptake on PET/MRI as SUV60 max, summarised by a mean and full range over the timeframe -21-0 days. The brief summary proposes that uptake may be higher in high-grade than lower-grade gliomas. A secondary outcome concerns uptake in relation to tumour type, histological grade, MGMT, and IDH gene expression.
The registry lists two outcome measures and zero analyses. It does not report uptake results, association estimates, statistical uncertainty, the analysis population, missing-data methods, or a statistical analysis plan. Safety counts list 10 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths.