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 Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors (NCT01619865), a na phase 1, phase 2 study. The primary outcome is To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01619865 |
| Phase | Phase 1, Phase 2 |
| Condition | Neuroendocrine Tumors, Carcinoid Tumors, Neuroblastoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 223 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sue O'Dorisio |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with somatostatin receptor positive tumors. The listed conditions include neuroendocrine tumors, carcinoid tumors, neuroblastoma, and medulloblastoma. The registry record describes diagnosis, staging, and assessment of response to treatment as intended uses of the scan. It does not report the detailed eligibility criteria or the number of enrolled participants in each diagnostic or treatment subgroup.
Intervention
Participants received 68Ga-DOTATOC PET/CT. The investigational radiopharmaceutical is described as a somatostatin-like peptide tagged with a radionuclide detectable by PET. The scan was intended to identify tumor lesions that take up 68Ga-DOTATOC and to support diagnosis, staging, and measurement of treatment response.
Comparator
The study goals describe comparison with Octreoscan SPECT plus high-resolution, contrast-enhanced CT. However, the registered design is single-group, with allocation listed as not applicable, and the registry record does not list a separate comparator arm. The comparison described as an objective should therefore not be read as a randomized, like-for-like treatment comparison.
Primary question
The registered primary endpoint asks how many adverse events related to 68Ga-DOTATOC were reported during the PET scan and 24 hours post scan. The broader study objectives also include diagnostic sensitivity and assessment of staging and treatment response. The registry record does not report results for those efficacy objectives, or a result for the primary endpoint that identifies the number of events judged related to the study drug.
In statistical terms, the primary safety question is about event frequency within a group exposed to the investigational radiopharmaceutical, rather than a difference in event frequency between assigned treatment groups. A count can describe the observed burden of reported events, but without a concurrent comparison group it cannot by itself establish how much of that burden is attributable to the study drug or scan procedure. The record states that some participants reported more than one adverse event, so event counts and participant counts are not interchangeable. It also does not report diagnostic accuracy estimates, response estimates, or an inferential comparison against the stated standard-of-care imaging approach.
3. Trial Design
NCT01619865 is registered as a phase 1 and phase 2 study with a single-group model. Allocation is listed as not applicable and masking as none. The registry lists 223 enrolled participants and a completed status. The listed intervention is 68Ga-DOTATOC PET/CT; the arm description identifies PET for diagnosis, staging, and measurement of response to treatment in somatostatin receptor positive tumors.
The study goals describe several uses of the imaging procedure: comparison with Octreoscan SPECT plus high-resolution, contrast-enhanced CT; evaluation of sensitivity in patients with suspected somatostatin receptor positive tumors; and measurement of response in participants who had recently received treatment. The registry record does not list a separate comparator arm. Consequently, the objectives should not be confused with a registered randomized comparison. The record does not report how the intended comparison was operationalized, which participants received each imaging approach, or whether paired imaging results were analyzed.
The registry gives a start date of 2012-02-21 and a primary completion date of 2017-08-27. It states that the study was designed with the long-term goal of supporting an application for approval of 68Ga-DOTATOC PET/CT in adults and children. That stated goal is not itself evidence of regulatory review or approval, and the registry record does not report such an outcome.
The record does not report a formal sample-size justification, enrollment targets by subgroup, or the statistical plan for the diagnostic and response objectives. It also does not report the number of participants who completed each imaging assessment or had evaluable data for each objective. These details matter because the overall enrollment does not establish how much information was available for any particular diagnostic question, tumor type, or treatment-response assessment.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Female subjects of childbearing potential were given a pregnancy test (serum) prior to receiving research-related radiation. A women who was pregnant could not participate in the study.
Overall Study
| Stage | 68Ga-DOTATOC PET/CT |
|---|---|
| STARTED | 223 |
| COMPLETED | 219 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | 68Ga-DOTATOC PET/CT |
|---|---|
| Adverse Event | 1 |
| Death | 2 |
| subject not able to comply | 1 |
Analysis population for the primary outcome, as defined in the registry: Subjects who reported an adverse event and relationship of adverse event to study drug (68Ga-DOTATOC). Several subjects reported more than one adverse event; thus, the number of subjects who experienced an event will be less than the number of events.
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.
Population: Subjects with known neuroendocrine tumor with lesion identified on CT or MRI. Subjects with suspected neuroendocrine tumor with no lesion identified on CT or MRI.
| Characteristic | Unit | 68Ga-DOTATOC PET/CT |
|---|---|---|
| Participants analysed | 223 | |
| Age, Categorical: <=18 years | Participants | 9 |
| Age, Categorical: Between 18 and 65 years | Participants | 32 |
| Age, Categorical: >=65 years | Participants | 182 |
| Age, Continuous | years | 53 (3 to 76) |
| Sex: Female, Male: Female | Participants | 136 |
| Sex: Female, Male: Male | Participants | 87 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 215 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| 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 | 209 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 8 |
| Region of Enrollment: United States | participants | 223 |
6. Primary Endpoint
The registry lists the primary outcome as To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent, measured over During PET scan and 24 hours post scan.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Adverse events reported |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events related to the investigational radiopharmaceutical agent, 68Ga-DOTATOC, during the PET scan and 24 hours post scan. The record describes an injection followed by whole-body PET, with participants queried about adverse events immediately after the scan and again 24 hours after completion. It also describes review of the scan by a certified nuclear medicine physician and grading of adverse-event severity according to NCI Common Terminology Criteria for Adverse Events version 4.0.
A count endpoint is useful for describing how many events were recorded during a defined observation window. The timing is relevant because the endpoint concerns events reported during and shortly after the scan, not all possible events over an unspecified longer follow-up period. The record notes that one participant may have reported more than one event; therefore, an event count can exceed the number of participants who experienced an event. Those two quantities answer different questions: one describes the number of events, while the other describes how many participants were affected.
The endpoint title specifies events related to the study drug, but the registry record does not report a primary endpoint count separated by the investigator’s assessment of relationship to 68Ga-DOTATOC. The adverse-event summary reports serious and other adverse-event counts, which should not automatically be treated as the endpoint result. The endpoint is intended to characterize observed safety events, but a count alone does not establish causation or provide a comparison with an unexposed group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record reports adverse-event summaries for the 68Ga-DOTATOC PET/CT group, with 223 participants at risk for serious adverse events and 223 at risk for other adverse events. It reports 1 participant affected by a serious adverse event and 176 affected by other adverse events. It also reports 2 deaths. These figures describe the posted safety summary; they do not, by themselves, establish that the serious events, other events, or deaths were caused by 68Ga-DOTATOC.
The primary endpoint is specifically framed around adverse events related to the investigational radiopharmaceutical during the scan and 24 hours afterward. The summary counts do not identify which events were judged related, and the registry record does not report a separate result for that primary endpoint. It is therefore important not to substitute the serious-event count or the count of participants with other events for the requested related-event endpoint. The record also notes that some participants experienced more than one event, so the number of events should not be equated with the number of participants affected.
The registry lists nausea, generalized or specific-area muscle weakness not due to neuropathy, and pain NOS among the top serious adverse-event terms, each reported as 0.4%. These listed terms provide information about the categories appearing in the serious-event summary. The record does not provide enough detail in this summary to determine whether they refer to distinct participants, whether the same participant had more than one term, or whether each event was judged related to the investigational agent. The percentages should be read as posted, not as evidence of a causal relationship.
No inferential analysis is reported: the registry lists zero analyses. It does not report confidence intervals, hypothesis tests, adjusted estimates, or an effect estimate comparing the scan with another imaging strategy. Without these, the precision of an estimated between-group difference cannot be assessed, and there is no registered randomized comparison from which to estimate such a difference. The adverse-event data are descriptive counts within the study group.
The study’s broader objectives include diagnostic sensitivity, staging, and response measurement. The registry record does not report results for those objectives, so the posted safety summary cannot establish diagnostic performance or treatment-response measurement performance. The overall enrollment of 223 does not indicate how many participants contributed usable data to each objective. No conclusion about the accuracy or comparative performance of the imaging strategy can be drawn from enrollment and safety counts alone.
Planning illustrations based on an observed effect, when displayed with the results, should be treated as hypothetical design calculations rather than evidence about what was achieved in this study. They are not observed power. In particular, an illustrative sample size does not compensate for unreported endpoint estimates, uncertainty intervals, or analysis details. The central interpretive limit is that the registry contains descriptive safety counts but does not report the primary related-event result or the planned diagnostic and response findings.
9. Statistical Methods Explained
The registered design is a single-group study. In a single-group design, outcomes are described among participants receiving the study intervention; there is no randomized arm-to-arm contrast in the registered design. The registry lists allocation as not applicable and masking as none. These design details are important when interpreting safety counts: a count within the exposed group describes what was observed, but does not on its own show what would have happened in the absence of the intervention.
The study goals mention comparison with Octreoscan SPECT plus high-resolution, contrast-enhanced CT. That objective does not change the registered design description. A comparison of imaging methods could require a defined paired or group-level analysis, but the registry record does not report the analysis structure, the evaluable sample for such a comparison, or results from it. No comparator group is listed in the registered arm information. Accordingly, there is no basis in the registry record for interpreting the posted adverse-event counts as a comparative treatment effect.
The primary outcome is a count of adverse events related to 68Ga-DOTATOC during the PET scan and 24 hours post scan. Count outcomes record how many events occurred, whereas participant-level outcomes record how many people experienced at least one event. If a participant experiences multiple events, these counts differ. The record explicitly notes that participants could report more than one event. This distinction is especially important when reading the summary, which separately gives affected-participant counts for serious and other adverse events but does not provide the primary endpoint count by relationship to the study drug.
The protocol description states that participants were queried immediately after the scan and again 24 hours after completion. This defines a short observation window for the stated primary safety assessment. A time window helps specify which reports contribute to an endpoint, but it does not describe events outside that window. The record does not report additional follow-up for this endpoint or a method for handling incomplete safety assessments. Therefore, the posted summary should not be read as a complete account of all possible later events.
The record says adverse-event severity was graded according to NCI Common Terminology Criteria for Adverse Events version 4.0. Severity grading is a standardized way to classify how serious an event is, but a severity grade and an assessment of causal relationship are distinct dimensions. An event can be severe without being judged related to the study drug, and an event judged related need not be serious. The registry summary does not provide the event-level grades or a cross-tabulation of severity with relationship, so those dimensions cannot be reconstructed from the posted counts.
General statistical explanation: uncertainty intervals, such as confidence intervals, describe the range of values reasonably compatible with observed data under a statistical model. They are particularly useful alongside an event rate or comparative estimate because a point estimate alone does not show how precisely it has been measured. The registry record does not report confidence intervals for the adverse-event counts, a related-event rate, or diagnostic estimates. No precision assessment of those quantities can therefore be made from the posted record.
General statistical explanation: comparisons between groups require attention to how participants entered each group and whether the groups are sufficiently comparable. Random allocation can support a causal comparison by balancing measured and unmeasured baseline factors on average, while a single-group study has no such concurrent randomized control. This does not make descriptive safety information uninformative, but it limits claims about attribution and relative risk. Here, the registry records a single group, and does not report a controlled estimate for safety or diagnostic performance.
The registry lists zero analyses. It does not report a statistical analysis plan, hypothesis tests, adjustment methods, or missing-data methods. In consequence, there is no basis to describe whether a particular model was used, whether results were adjusted for participant characteristics, or how the analysis treated participants without a complete assessment. These are not details that can be inferred from the endpoint description alone.
The registry record also does not report a sample-size justification for the trial. Any planning illustrations calculated from an observed effect use stated assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Time-to-event illustrations use the total number of events; other illustrations give participants per arm. These are planning conventions, not the study’s own design justification. Since the registered study is single-group and no analysis is reported, such illustrations should not be interpreted as the observed power of this trial. More generally, sample-size planning illustrates the size of a study that might be needed under assumptions; it does not show the precision or reliability of results actually observed.
Over-dispersion is a general concern for count data when variation exceeds what a simple count model assumes. If present, it can make a model understate uncertainty unless the analysis accounts for the extra variation. The registry record does not report a count model or a dispersion assessment, so there is no basis to say whether over-dispersion was evaluated in this study. This point is relevant as general statistical context, not a description of an analysis known to have been conducted.
10. Multiplicity, Missing Data and Analysis Populations
The study description includes several objectives: safety, comparison with another imaging approach, diagnostic sensitivity, staging, and measurement of response to treatment. When a study evaluates multiple endpoints or questions, multiplicity can arise because testing many hypotheses increases the chance of at least one apparently notable result by chance. A statistical plan may identify a primary question, define secondary questions, and specify whether or how multiplicity is addressed. The registry identifies a primary safety endpoint, but the registry record does not report a multiplicity strategy or a statistical analysis plan for the broader objectives.
The registry lists zero analyses and does not report p-values, confidence intervals, or inferential estimates for the listed objectives. As a result, there are no reported hypothesis-test results to interpret as adjusted or unadjusted for multiple comparisons. It would not be appropriate to assume that a correction was applied, or that none was needed, based only on the objective descriptions.
The registry record does not report missing-data methods, the number of participants with incomplete safety assessments, or the analysis population used for each outcome. It also does not report how many enrolled participants had evaluable imaging for diagnosis, staging, or response. These omissions limit interpretation because the overall enrollment does not indicate the amount of usable information for each endpoint. If participants with incomplete assessments differed from those with complete data, the results could be affected; the record does not provide information to assess that possibility.
The short safety observation window is stated as during the PET scan and 24 hours post scan. The record does not report how missed queries or incomplete follow-up within that window were handled. It also does not report whether safety results were analyzed by all enrolled participants, participants who received the injection, or another defined population. These analysis-population and missing-data details 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 |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | 1 | 223 | 0.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 68Ga-DOTATOC PET/CT | 2 of 223 |
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 |
|---|---|
| 68Ga-DOTATOC PET/CT | 176 of 223 |
Most frequent serious adverse event terms
| Event term | Organ system | 68Ga-DOTATOC PET/CT |
|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 223 |
| Muscle weakness, generalized of specific area (not due to neuropathy - Whole body/generalized | Musculoskeletal and connective tissue disorders | 1 of 223 |
| Pain NOS | General disorders | 1 of 223 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 68Ga-DOTATOC PET/CT |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | 15 of 223 |
| Nausea | Gastrointestinal disorders | 13 of 223 |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | 13 of 223 |
| Hemoglobin | Hepatobiliary disorders | 12 of 223 |
| Lymphopenia | Hepatobiliary disorders | 11 of 223 |
| Pain - Abdomen NOS | Musculoskeletal and connective tissue disorders | 11 of 223 |
| Sweating (diaphoresis) | General disorders | 7 of 223 |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 7 of 223 |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | 7 of 223 |
| Flushing | Skin and subcutaneous tissue disorders | 6 of 223 |
Serious events with the highest arm-level rate: nausea (0.4%), muscle weakness, generalized of specific area (not due to neuropathy - whole body/generalized (0.4%), pain nos (0.4%).
The safety summary lists 223 participants at risk for serious adverse events and 1 affected by a serious adverse event. For other adverse events, it lists 223 at risk and 176 affected. It also lists 2 deaths. These are separate summary categories and should not be combined into a new total. The record notes that individual participants may have had more than one event, so counts of events need not equal counts of affected participants.
The top serious-event terms listed are nausea, generalized or specific-area muscle weakness not due to neuropathy, and pain NOS. Each is reported as 0.4%. Those entries describe the posted serious-event terms; they do not establish that the terms were caused by 68Ga-DOTATOC, nor do they show whether the same or different participants contributed to the terms. The registry record does not report the relationship assessment for each listed term.
The primary endpoint concerns adverse events related to the investigational radiopharmaceutical during the scan and 24 hours afterward. The summary figures above do not identify the count judged related within that time window, so they should not be treated as a direct result for that endpoint. The registry record also does not report cause of death or state whether the deaths were related to the study drug or procedure. The counts are descriptive observations, not proof of causation or comparative risk.
12. What the Result Does, and Does Not, Mean
The record establishes that the study evaluated 68Ga-DOTATOC PET/CT in a registered single-group study and reports a safety summary for the intervention group. It identifies the intended primary safety question, the assessment window, and the use of CTCAE v4.0 for severity grading. It also reports the number of participants affected by serious and other adverse events, alongside deaths and selected serious-event terms. Those details provide a descriptive account of the posted safety information.
The registry record does not report the number of adverse events judged related to the investigational radiopharmaceutical, even though that is the stated primary endpoint. It therefore does not provide the result needed to directly answer the primary question as written. The serious and other adverse-event counts cannot replace that missing result because the summary does not identify causal relationship for each event. Nor can the counts establish whether an event was caused by the imaging procedure, the radiopharmaceutical, the underlying condition, or another factor.
The broader aims include diagnostic sensitivity, staging, and measurement of response to treatment, as well as comparison with Octreoscan SPECT plus high-resolution, contrast-enhanced CT. The registry record does not report results for these aims. In particular, no sensitivity estimate, comparative diagnostic result, or treatment-response estimate is available in the record. The stated objectives should not be mistaken for findings.
The record also does not report confidence intervals or other uncertainty estimates for the posted safety data. The descriptive counts can be read as observations in the study group, but their precision and generalizability cannot be fully assessed from the registry summary alone. Enrollment of 223 does not show how many participants contributed complete data to any particular outcome. These limits mean the posted record supports a description of reported safety counts, not a firm conclusion about causality, comparative performance, or diagnostic effectiveness.
13. Why This Trial Matters Statistically
This study raises several statistical issues that are common in imaging and safety research. First, its primary question is a count of adverse events related to an investigational radiopharmaceutical, while the posted safety summary gives counts of participants affected by serious and other events. Event counts and participant counts answer different questions, and a count of all events is not interchangeable with a count restricted to events judged related. Keeping these endpoint definitions distinct is essential to avoid overstating what the record establishes.
Second, the record illustrates why design structure matters. A single-group study can describe observed events and imaging assessments, but it does not provide a randomized concurrent group for estimating comparative safety or performance. The study objectives describe comparison with another imaging approach, yet the registry does not list a comparator arm or report the corresponding analysis. The distinction between an objective and a registered design is important when assessing whether an estimate can support a comparative claim.
Third, the record identifies multiple scientific aims, including safety and diagnostic or response questions, but does not report analyses or results for those aims. A clear analysis plan would ordinarily explain which question is primary, how additional questions are handled, what data are included, and how missing assessments are treated. Those details are not reported in the registry record, limiting reproducibility and interpretation.
Finally, sample-size planning and observed evidence serve different purposes. Planning illustrations based on assumptions can help describe what a future study might require, but they are not observed power and cannot supply missing outcome estimates or uncertainty intervals. For this record, the most important statistical lesson is to separate the posted descriptive counts from unreported endpoint analyses and from the broader objectives that have no results reported in the registry.
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 is incomplete reporting of results in the registry record. Although safety is identified as the primary endpoint, the record does not report a primary result giving the number of adverse events judged related to 68Ga-DOTATOC. The summary does report serious and other adverse-event counts, but not a breakdown by relationship to the agent. This prevents a direct reading of the endpoint as registered.
The study is described as single-group, with no masking and allocation listed as not applicable. The study goals mention comparison with Octreoscan SPECT plus high-resolution, contrast-enhanced CT, but the registry does not list a comparator arm or report results from that comparison. The available design information therefore does not support a randomized comparative interpretation.
The record does not report results for diagnostic sensitivity, staging, or treatment-response measurement. It also does not report participant flow, subgroup enrollment, evaluable imaging counts, missing-data handling, analysis populations, or an analysis plan. Overall enrollment cannot clarify how many participants had usable observations for each objective, and the precision of the outcomes cannot be assessed because confidence intervals and related inferential results are not reported.
For safety, the listed observation window is during the scan and 24 hours post scan. The registry does not report whether later adverse events were assessed, how incomplete assessments were handled, or whether deaths were considered related to the intervention. The event terms and percentages in the serious-event summary do not establish causation. These limits are specific to the information recorded for this study and restrict conclusions to the descriptive information actually posted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors — NCT01619865.
- Registry record last updated 2021-07-27; status last verified 2021-07.
- Results first posted 2021-02-02.
- 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
NCT01619865 is a completed phase 1 and phase 2, single-group study of 68Ga-DOTATOC PET/CT in patients with somatostatin receptor positive tumors. The registry lists 223 enrolled participants, no masking, and an allocation status of not applicable. The primary endpoint concerns adverse events related to the investigational radiopharmaceutical during the scan and 24 hours post scan.
The adverse-event summary reports 1 participant affected by a serious adverse event and 176 affected by other adverse events among 223 at risk in each category, and lists 2 deaths. Selected serious-event terms are reported at 0.4% each. The registry record does not report the primary related-event count, diagnostic or response results, inferential analyses, or uncertainty estimates. The posted information is therefore descriptive and does not establish causality or comparative imaging performance.