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 Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer (NCT03510988), a na na study. The primary outcome is Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03510988 |
| Phase | NA |
| Condition | Newly Diagnosed Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
Population
Women over age 25 with newly diagnosed breast cancer for whom a breast MRI had been ordered as standard care. The study was conducted at a single institution. The registry reports enrollment of 14.
Intervention
Hybrid dedicated breast FDG PET/MRI used to evaluate extent of disease before surgical and oncologic management. The study description says it was used in place of breast MRI alone.
Comparator
MRI alone, used as a comparison for lesion assessment. This is not a randomized comparison between separately assigned treatment groups; the study is recorded as single-group.
Primary question
Among benign or non-malignant lesions, what percentage are correctly identified as negative by PET/MRI, and how does that specificity compare with MRI alone?
The question is diagnostic rather than therapeutic. It concerns whether adding concurrent PET to breast MRI changes the classification of lesions that are benign or non-malignant. Specificity focuses on this group: a true negative is a benign or non-malignant lesion assessed as not suspicious for malignancy. It does not, by itself, describe how often malignant lesions are detected; sensitivity addresses that distinct aspect of diagnostic performance.
The study description places imaging before surgical and oncologic management. It frames PET/MRI as an examination performed in lieu of MRI alone, while the primary endpoint compares lesion assessments from PET/MRI and MRI alone. The record does not report a numerical specificity estimate, the lesion counts behind the comparison, or a numerical difference between the imaging assessments. The intended clinical question is therefore identifiable, but its result cannot be quantified from the registry record.
3. Trial Design
This was a single-institution, single-group diagnostic imaging study in women with newly diagnosed breast cancer. Eligible participants were described as women over age 25 for whom breast MRI had been ordered as standard care. The intervention was hybrid dedicated breast FDG PET/MRI, performed to evaluate extent of disease before surgical and oncologic management and in place of breast MRI alone. Enrollment is listed as 14.
The registry records allocation as not applicable and masking as none. It does not describe a randomized assignment to PET/MRI or MRI-only groups. Instead, the primary endpoint description says that blinded breast imaging readers received anonymized PET/MRI and MRI-alone studies from the study cohort in a reading list presented at random. The random ordering of reading material should not be mistaken for random allocation of participants to imaging groups. The record does not provide further detail about reader numbers, reader expertise, or the precise reading procedures.
The study began on 2018-03-15, and the primary completion date is listed as 2020-03-04. Its status is terminated. The reason for termination, whether recruitment or follow-up ended as planned, and how termination affected data collection are not reported in the registry record. The phase is recorded as not applicable.
The description states that intravenous FDG and Gadolinium were injected once before the study according to protocol and weight. The text about every second consecutively recruited patient is incomplete in the registry record, so it does not support a fuller account of that procedure. No separate parallel control arm is described. Consequently, the comparison of interest is a diagnostic comparison within the study’s imaging assessments, not evidence from randomized groups.
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 | Women With Newly Diagnosed Breast Cancer |
|---|---|
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Women With Newly Diagnosed Breast Cancer |
|---|---|---|
| Participants analysed | 14 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 13 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 14 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer, measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 90% Confidence Interval |
| Unit | percentage of true negative |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is specificity of PET/MRI compared with MRI alone, defined in the record as the percentage of true negatives among all benign or non-malignant lesions. A true negative is a lesion in that benign or non-malignant category that readers assess as not suspicious for malignancy. The record describes blinded breast imaging readers assessing anonymized examinations and comparing the lesion assessments from PET/MRI with those from MRI alone.
Specificity is used to describe performance among lesions that are not malignant. It addresses how often the imaging assessment correctly avoids a suspicious classification in that group. It is complementary to sensitivity, which concerns detection among malignant lesions. Neither measure alone describes every aspect of diagnostic performance, and specificity should be interpreted alongside the clinical and study context.
The endpoint’s timeframe is 24 months. The record specifies a 90% confidence interval as the measure of uncertainty around the percentage, but does not report the primary endpoint estimate, its interval limits, the number of benign or non-malignant lesions assessed, or the reader-level results. These quantities are not reported in the registry record. Without the estimate and its underlying counts, the direction and precision of the comparison cannot be evaluated from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a focused diagnostic question: compare PET/MRI and MRI-alone assessments of specificity for breast lesions judged benign or non-malignant. It does not include the numerical result for that primary endpoint. The value of specificity, its 90% confidence interval, the corresponding MRI-alone result, and the counts of true-negative and benign or non-malignant lesions are not reported in the registry record. As a result, the posted information does not establish which assessment had higher specificity or how large or precise any difference might be.
The record lists 14 enrolled participants and indicates that the readers reviewed anonymized examinations from the study cohort. Participant enrollment is not the same as the number of lesions evaluated: a participant may contribute more than one lesion, and the record does not give the lesion counts. Nor does the enrollment figure reveal how many examinations were available for each imaging assessment or how many participants contributed usable primary-endpoint data. Those details are not reported in the registry record.
General statistical interpretation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. For a diagnostic percentage based on a limited number of lesions, the estimate may be imprecise; the relevant interval and the number of observations are needed to judge that uncertainty. Because neither the estimate nor interval limits are reported, no conclusion about precision is possible for this endpoint.
The record specifies a 90% confidence interval and describes the primary measure as a percentage of true negatives. It does not report a hypothesis test, a p-value, a prespecified threshold for a meaningful difference, or a statistical model. These items are not reported in the registry record. The endpoint description also does not establish whether the comparison accounts for multiple lesions from the same participant or for repeated assessments by readers. That matters statistically because observations from the same participant or reader may be related rather than independent.
The study is recorded as single-group, with no randomized participant allocation. Although MRI alone is the comparator in the diagnostic question, that does not create a randomized control group. Imaging assessments can be compared, but the record does not report a numerical comparison or sufficient details to assess its statistical handling. The status is terminated, but no reason or effect of termination is reported. Termination alone does not reveal the direction, validity, or completeness of the endpoint findings.
In short, the registry record documents the intended comparison and the planned confidence-interval format, but does not report a numerical primary result. Interpretation should remain limited to those details rather than inferring diagnostic performance from enrollment, study status, or the existence of a stated endpoint.
9. Statistical Methods Explained
The registry describes the primary endpoint as a percentage of true negatives among benign or non-malignant lesions. This is a proportion: the numerator is the number of lesions classified as true negatives, and the denominator is all benign or non-malignant lesions in the endpoint definition. No numerator or denominator is reported in the registry record, so the percentage cannot be reconstructed from the posted information. The number of participants enrolled is not a substitute for the endpoint denominator, because the endpoint is lesion-based.
What does specificity describe?
General explanation: specificity describes how often a diagnostic assessment classifies non-diseased cases as negative. It is distinct from sensitivity, which describes detection among diseased cases. A highly specific assessment may generate fewer false-positive classifications among non-diseased cases, but specificity does not by itself quantify sensitivity, predictive values, or the consequences of diagnostic decisions. Those measures answer different questions and depend on their own definitions and data.
The record’s primary outcome compares specificity for PET/MRI and MRI alone. Readers were given anonymized studies from the cohort, and the record says the reading list was presented at random. It also describes the readers as blinded. The registry does not explain exactly what information readers were blinded to, how images were ordered or paired, whether readers made independent assessments, or how disagreements were handled. These procedural details are not reported in the registry record.
How should the confidence interval be read?
The endpoint description specifies a 90% confidence interval. General explanation: a confidence interval is a range calculated using a statistical procedure to express uncertainty about an estimated quantity. It should be considered together with the estimate and the data contributing to it. A confidence interval is not a guarantee that the true value lies within the particular reported interval, and it does not by itself determine whether an observed difference is important.
No numerical interval limits or endpoint estimate appear in the registry record. It is therefore not possible to discuss the observed precision, whether the interval spans a meaningful range, or whether the estimate is compatible with substantially different values. The registry record also does not state a clinically meaningful threshold for the difference in specificity.
Why does the study structure matter?
The study is recorded as single-group, and participant allocation is not applicable. The comparison is between diagnostic assessments, not between treatment groups assigned through randomization. Random ordering of anonymized studies for readers concerns the reading process; it does not make the participant-level study a randomized trial. This distinction limits what can be inferred from the design and avoids treating MRI alone as a separately randomized control arm.
General explanation: comparisons of diagnostic tests may involve paired assessments, since the same participant or lesion can be assessed with more than one method. Paired observations can be statistically related. If multiple lesions belong to one participant, those lesions may also be correlated. Such dependence affects uncertainty calculations; treating related observations as independent can make uncertainty appear smaller than it is. The registry record does not report enough analysis detail to determine whether or how dependence among lesions, participants, or readers was handled.
What is known about the analysis plan?
The registry lists no analyses. It does not report a statistical analysis plan, a hypothesis test, a model, adjustment factors, handling of missing data, or an analysis population for the primary endpoint. These details are not reported in the registry record. The absence of such information does not establish that no analysis was performed; it means the analysis methods cannot be evaluated from this record.
General explanation: an analysis plan ordinarily clarifies which outcomes will be evaluated, how observations are defined, how uncertainty is estimated, and how missing or unusable measurements are handled. For diagnostic outcomes, definitions of disease status, lesion matching, and reader decisions can be particularly important. Without those details and the actual estimates, readers cannot assess whether the reported endpoint implementation fully follows the stated definition.
What do planning calculations mean?
General explanation: sample-size calculations are prospective planning tools. They can illustrate the number of participants per arm needed under specified assumptions, but they are not evidence that an observed effect is real, nor are they a substitute for reported study results. The record describes its planning assumptions as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These assumptions do not describe the recorded single-group study design, and the record does not provide a numerical observed effect in the information available for this endpoint. Any planning illustration should therefore be understood as hypothetical, not as observed power or as a result of this study.
General explanation: over-dispersion occurs when observed variability exceeds what a simple statistical model assumes. It can affect standard errors and confidence intervals. The registry record does not report a model or a finding of over-dispersion, so there is no basis to say that it was present or that a particular adjustment was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six secondary outcomes in addition to the primary specificity question. They include sensitivity, positive and negative predictive values, signal-to-noise summaries in relation to FDG dosages, interval recurrences, lymph-node metastasis detection, and perceived patient benefit. The record does not report numerical results for these outcomes in the information. It also lists no analyses, and a detailed statistical analysis plan is not reported in the registry record.
When a study evaluates multiple outcomes, readers generally consider whether the analysis plan addressed multiplicity. General explanation: testing or estimating many outcomes can increase the chance that at least one result appears notable by chance, depending on the methods and interpretation. The registry does not report whether any multiplicity strategy was planned or used, so no adjustment or hierarchy among outcomes should be assumed. The specified 90% confidence interval for the primary endpoint does not, on its own, establish how other outcomes were handled.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not state how unavailable examinations, uninterpretable lesions, incomplete reader assessments, or missing follow-up were handled. It does not identify whether the primary endpoint used all enrolled participants, an evaluable subset, or another defined population. This distinction matters because enrollment does not necessarily equal the set contributing data to a specific diagnostic endpoint.
The study status is terminated, but the reason for termination and its relationship to data completeness are not reported. It would be inappropriate to infer that termination caused missing data or that the results are biased. The available record does not provide enough information to assess either possibility.
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 |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Women With Newly Diagnosed Breast Cancer | 0 of 14 |
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 |
|---|---|
| Women With Newly Diagnosed Breast Cancer | 0 of 14 |
The registry lists safety figures for the group of women with newly diagnosed breast cancer. It records 14 at risk for serious adverse events and 0 with serious adverse events; it also records 14 at risk for other adverse events and 0 with other adverse events. Deaths are listed as 0. These are the counts reported in the registry record.
These figures should be read as reported counts, not as a complete description of the safety profile. The record does not provide event terms, event severity details beyond the serious-versus-other categories, the observation period for safety reporting, or information about how events were collected. No serious-event terms are listed. The zero counts do not establish that no event could occur or that the intervention has no risks; they state only what the registry reports for this group.
The group-level safety counts do not provide a randomized comparison, since the study is recorded as single-group and has no participant allocation to separate comparator groups. They also should not be converted into percentages without additional calculations. The posted record supports reporting the counts as listed, while broader conclusions about safety are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a single-institution study evaluated hybrid dedicated breast FDG PET/MRI in women with newly diagnosed breast cancer. It identifies specificity among benign or non-malignant lesions as the primary endpoint and describes MRI alone as the comparator. It also specifies a 90% confidence interval and gives a 24-month timeframe. These details clarify the intended diagnostic question.
What the record does not establish is the numerical answer. It does not report the primary specificity estimate, the corresponding MRI-alone estimate, the confidence-interval limits, the lesion counts, or a numerical difference between assessments. No conclusion about the comparative performance or precision of the imaging assessments can be drawn from the registry record. The record also does not report the listed secondary outcome results or an analysis method sufficient to independently assess them.
The enrollment figure of 14 describes participants, not the number of lesions used in the primary calculation. It cannot be used to reconstruct diagnostic specificity. Similarly, the record’s terminated status does not explain why the study stopped, whether data collection was complete, or what effect termination had on the results. Those points are not reported in the registry record.
General explanation: a diagnostic study’s result is most informative when the estimate, its uncertainty, the underlying counts, and the case definitions are available together. The estimate describes observed performance in the evaluated data; uncertainty indicates how precisely that performance is estimated. A study design and a stated endpoint alone do not supply the missing outcome evidence.
The safety figures should likewise be interpreted narrowly as registry counts. They list zero serious adverse events, zero other adverse events, and zero deaths in the group reported. They do not by themselves establish a general safety conclusion. Overall, the available information describes the study’s purpose and design, but does not report the primary numerical result needed to answer its stated comparison.
13. Why This Trial Matters Statistically
This study is statistically interesting because it asks a diagnostic question involving specificity, rather than evaluating a therapeutic outcome. Specificity concerns correct negative assessments among benign or non-malignant lesions. The endpoint definition therefore makes clear which type of classification error is central to the primary question, while sensitivity and predictive values address other aspects of diagnostic performance.
The record also illustrates why the unit of analysis matters. Participants were enrolled, but the endpoint is defined at the lesion level. Without the number of lesions, their distribution across participants, and the method used to account for related observations, the precision of the endpoint cannot be evaluated. General explanation: multiple lesions from one person may share characteristics, so they should not automatically be treated as statistically independent.
A further statistical distinction is between random reading order and randomized study allocation. The record describes anonymized studies presented to readers at random, but the design is listed as single-group with allocation not applicable. Random ordering can concern how material is reviewed; it does not make this a randomized comparison of participants assigned to different imaging strategies.
The registry specifies a confidence-interval approach for the primary endpoint, which is useful for recognizing that an estimate should be interpreted with uncertainty. However, no estimate or interval limits are reported. That makes the case an important reminder that a clearly stated endpoint and design do not replace outcome reporting. The record communicates what the study set out to assess, but does not report the numerical evidence necessary to judge the observed specificity comparison.
The listed planning assumptions also illustrate a separate distinction: planning calculations are not observed study findings. Assumptions about allocation and a target effect can be used for hypothetical design illustrations, but they do not change the recorded single-group structure or supply a missing primary result.
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 central limitation for interpretation is that the primary endpoint result is not reported in the registry record. The specificity estimate, its 90% confidence interval limits, the MRI-alone estimate, and the counts underlying each assessment are absent. Consequently, the comparative result and its precision cannot be assessed.
The study is recorded as single-group, with no randomized allocation. The diagnostic comparison with MRI alone is not a randomized participant-level control comparison. The registry does not provide enough detail about the reading design to establish how assessments were paired, whether reader-level variation was accounted for, or how multiple lesions from one participant were handled. These analysis details are not reported in the registry record.
The entry lists enrollment of 14, but does not report the number of lesions or examinations contributing to the primary endpoint, the number of readers, or the analysis population. It does not report a statistical analysis plan, missing-data methods, adjustment for multiplicity, or a hypothesis-testing approach. The termination reason and its effect on follow-up or outcome availability are also not reported.
The arm-description text about every second consecutively recruited patient is incomplete, limiting interpretation of that procedural detail. The available record also does not describe reader experience, lesion verification procedures, or how the benign/non-malignant classification was established. These details may affect interpretation of diagnostic-performance estimates, but no assumptions about them are warranted.
Finally, the safety record presents aggregate counts without event terms or collection details. This limits conclusions about the nature and completeness of safety reporting. None of these omissions demonstrates that a method was absent or that the findings are invalid; they mark what cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer — NCT03510988.
- Registry record last updated 2023-02-22; status last verified 2023-01.
- Results first posted 2023-02-22.
- 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
The registry describes NCT03510988, a terminated, single-institution, single-group study of dedicated breast FDG PET/MRI in women with newly diagnosed breast cancer. Enrollment is listed as 14. Participants were described as women over age 25 for whom breast MRI had been ordered as standard care. PET/MRI was used to assess extent of disease before management, in lieu of MRI alone.
The primary endpoint was specificity among benign or non-malignant lesions, with a 90% confidence interval and a 24-month timeframe. The record describes blinded reader assessment of anonymized PET/MRI and MRI-alone studies, but does not report a numerical primary result or its underlying counts. Six secondary outcomes are listed, with no analyses listed.
The registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths. The reason for termination, analysis populations, missing-data methods, detailed statistical methods, and numerical endpoint results are not reported in the registry record.