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 Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer (NCT07216274), a na na study. The primary outcome is Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT07216274 |
| Phase | NA |
| Condition | Breast Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Mayo Clinic |
| Results posted | Yes |
2. Clinical Question
Population
Patients with high lifetime risk of breast cancer are the stated study population. The summary describes QTI as an initial evaluation method for asymptomatic women identified as having above-average risk. The registry record does not report further eligibility details or participant characteristics.
Intervention
The study intervention is quantitative transmission imaging using a QT Ultrasound Breast Scanner. The summary describes QTI as a single 3D ultrasound test intended for supplemental screening. Patients in the Screening (QTI) group undergo QTI ultrasound imaging on study.
Comparator
MRI is the standard-of-care imaging modality against which QTI interpretations are evaluated. The registry record describes MRI and QTI interpretations for the patients, but does not describe a randomized, like-for-like control group. The comparison is therefore between imaging interpretations rather than between separately assigned treatment arms.
Primary question
The primary outcome counts findings from total MRI interpretations and total QTI interpretations at baseline. Positive findings are counted, with imaging characteristics, size, location, and BI-RADS score recorded for each finding. The registry record does not report whether the observed counts differed or what those counts were.
In statistical terms, the question concerns how the two imaging modalities identify and characterize findings in this study population. It is not a comparison of health outcomes, nor does the posted outcome alone establish whether a finding represents cancer. The record states that, if biopsies are obtained, findings will be compared with histopathologic diagnosis; whether biopsies were obtained and the resulting diagnoses are not reported in the registry record.
3. Trial Design
This is a completed, single-group device study registered as NCT07216274. The sponsor is Mayo Clinic. The study started on 2025-07-31, and primary completion is recorded as 2025-10-20. The registry lists the phase and allocation as NA and masking as none. Enrollment is 26. The condition listed is breast carcinoma.
The Screening (QTI) group undergoes QTI ultrasound imaging on study. The interventions also include questionnaire administration. The registry describes each breast as interpreted separately for each imaging modality, yielding 52 MRI interpretations and 52 QTI interpretations for the 26 patients. These are interpretation counts, not separate participant groups. The registry specifically cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison.
The primary outcome is a count of findings for the total MRI interpretations and total QTI interpretations, with a baseline timeframe. The record describes positive findings as the basis for counting and notes that imaging characteristics, size, location, and BI-RADS scores are recorded. If biopsies are obtained, findings are to be compared with histopathologic diagnosis.
The registry lists one outcome measure and no statistical analyses. It does not report a detailed analysis plan, a sample-size justification, eligibility criteria beyond the stated high-risk population, or how the questionnaire is used in the analysis. The listed enrollment should not be taken as evidence that every planned analysis was completed, particularly because outcome results are not reported in the registry record.
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 | Screening (QTI) |
|---|---|
| STARTED | 26 |
| COMPLETED | 26 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: For the 26 patients, each breast was interpreted separately for each imaging modality, yielding 52 MRI interpretations and 52 QTI interpretations.
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 | Screening (QTI) |
|---|---|---|
| Participants analysed | 26 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 |
| Age, Categorical: >=65 years | Participants | 5 |
| Sex: Female, Male: Female | Participants | 26 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 26 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 22 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Region of Enrollment: United States | Participants | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of findings |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of positive findings recorded across total MRI interpretations and total QTI interpretations at baseline. Each breast is interpreted separately for each modality. For each finding, the planned recorded features include imaging characteristics, size, location, and a BI-RADS score. If biopsies are obtained, findings are to be compared with histopathologic diagnosis.
A count endpoint describes how many findings meet the stated positive-finding definition; it does not, by itself, establish that findings are cancer or show how accurately a modality identifies disease. A finding count can help describe the output of imaging, while information about diagnosis is needed to assess whether findings correspond to disease. The registry record does not report the positive-finding definition in further operational detail, nor does it report biopsy uptake or pathology results.
Because the same study population contributes interpretations for both modalities, the relevant observations may be related rather than independent. General statistical practice is to account for such pairing when comparing modalities; treating related observations as independent can misstate uncertainty. The registry record does not report the method used to compare the counts, or any effect estimate or uncertainty interval. No primary endpoint results are reported in the registry record, so the direction and precision of any difference cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the outcome to be measured but does not post its results. It therefore does not establish how many positive findings were recorded for MRI or QTI, whether their counts were similar or different, or how uncertain any comparison might be. No effect estimate, confidence interval, or analysis result is reported in the registry record. The study status is completed, but completion alone does not supply evidence about the primary outcome.
The outcome is based on interpretations, not independent groups of participants: the record states that each breast was interpreted separately with each modality. It reports 52 MRI interpretations and 52 QTI interpretations for the 26 patients. Those interpretation totals should not be read as participant totals or as independent observations. General statistical reasoning indicates that measurements from the same person can be correlated. A comparison that accounts for the within-person structure can have different uncertainty from an analysis that ignores it. The registry record does not say how that structure was handled.
Counts of positive findings are also not interchangeable with counts of confirmed cancers. The record says biopsy findings, if biopsies are obtained, will be compared with histopathologic diagnosis, but it does not report whether biopsies occurred or provide pathology results. Without such diagnostic information, the posted endpoint as described can characterize imaging findings but cannot establish how many findings were true positives, false positives, or false negatives. Those classifications require information beyond the count of positive findings.
The record lists no statistical analyses. It does not report a formal comparison, uncertainty quantification, adjustment for paired interpretations, or subgroup analyses. Thus, no inferential conclusion about a modality difference can be drawn from the registry record. In particular, the absence of a reported analysis is not evidence that the modalities produced equal counts.
The adverse-event fields for the Screening (QTI) group show zero counts for the listed serious, other, and death categories. These recorded zeros should be interpreted narrowly: they describe the registry entries and do not, on their own, establish that no adverse events occurred or that safety was comprehensively assessed. No further adverse-event terms are listed. The registry record does not report the collection or adjudication procedures for safety outcomes.
Overall, the record supports a description of the study design, population size, imaging interpretation counts, and intended endpoint. It does not provide the results needed to estimate a difference, evaluate precision, or assess diagnostic performance. Any stronger conclusion would go beyond the information reported in the registry record.
9. Statistical Methods Explained
The primary outcome is expressed as a count of findings. A count records how many events or items meet a specified definition within an observation unit. Here, the outcome description refers to positive findings among MRI and QTI interpretations at baseline. Counts can be useful for describing imaging output, but interpretation depends on the unit being counted, how a positive finding is defined, and whether multiple findings can occur within an interpretation. The registry record does not report additional operational details about the positive-finding definition.
Count data are often analyzed with models designed for nonnegative integer outcomes. A basic count model commonly assumes that the mean and variance follow a particular relationship. In practice, observed counts may be more variable than that assumption allows; this is called over-dispersion. General statistical practice is to consider whether the model adequately represents the variability, because underestimated variability can make confidence intervals too narrow and tests too optimistic. The registry record does not report a count model, a dispersion assessment, or any model results, so no claim can be made about how these issues were handled in this study.
The interpretation structure matters as well. The registry says the same 26 patients contributed breast-level interpretations for both modalities, with 52 MRI interpretations and 52 QTI interpretations. Observations from the same person or breast are often correlated. A paired analysis, or a model that accounts for clustering, can represent this dependence. A method that assumes all interpretations are independent may not do so. These are general methodological considerations, not a statement about the study’s actual analysis: the registry record lists no statistical analyses and does not identify an approach to pairing or clustering.
A confidence interval is a range of values compatible with the data and the assumptions of the analysis. It communicates uncertainty around an estimate; it does not by itself show whether the estimate is clinically important or free of bias. A narrow interval can indicate relatively precise estimation under the model, while a wide interval indicates less precision. No confidence interval or other uncertainty measure for the primary outcome is reported in the registry record. Precision therefore cannot be evaluated from the posted outcome information.
A difference in the number of findings would not automatically be a difference in diagnostic accuracy. Accuracy requires a reference standard that classifies disease status. The registry description says that if biopsies are obtained, imaging findings will be compared with histopathologic diagnosis. This describes a possible reference-standard comparison, but the record does not report biopsy completion, pathology findings, or diagnostic performance measures. A positive imaging finding should therefore be understood as an imaging result, not as a confirmed diagnosis.
The registry’s sample-size assumptions describe a planning illustration based on the 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 stated as a fraction of the observed effect. The record also distinguishes total-event planning for time-to-event outcomes from participants-per-arm planning for other outcomes. These are general planning assumptions, not evidence of the trial’s original design or justification. The record does not report the trial’s own sample-size justification. The study is described as single-group, and the registry cautions that its arms are not a like-for-like control comparison. Any sample-size illustration based on a hypothetical two-arm design should not be treated as a design feature of this study or as observed power. Planning calculations describe what might be required under specified assumptions; they do not establish the reliability of an observed result.
Multiplicity arises when several outcomes, contrasts, or subgroup tests are assessed. Repeated testing can increase the chance of at least one apparently notable result arising by chance. The registry lists one outcome measure and no analyses, but it does not report whether additional analyses were planned or whether multiplicity was addressed. It is therefore not possible to assess a multiplicity strategy. A single listed primary outcome does not reveal the full set of analyses that may have been considered.
Missing-data methods are also not described. Missing interpretations, unavailable imaging, or absent pathology could affect how a comparison is interpreted, but the registry does not report whether any such data were missing or how they were handled. The analysis population is not reported in the registry record. These omissions limit the ability to reproduce or evaluate a statistical analysis, independently of the fact that primary results are not posted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no statistical analyses. It does not report a multiplicity plan, such as how inference would be handled if multiple contrasts, outcome definitions, or subgroup analyses were examined. Without an analysis record, it is not possible to determine which comparisons were conducted or whether any adjustment for multiple testing was used. The listed outcome count alone does not establish that no other analyses were considered.
Missing-data handling is not reported in the registry record. The record does not state whether any MRI or QTI interpretations were unavailable, whether findings lacked recorded characteristics, or whether biopsies and pathology results were missing. It also does not describe an approach for incomplete observations. These details matter because exclusion or incomplete ascertainment can affect both the count being analyzed and the population to which an estimate applies.
The analysis population is not reported in the registry record. Although enrollment and interpretation totals are stated, the record does not explain whether all enrolled patients contributed to the primary outcome analysis or how any unavailable data would be treated. No statistical analysis results are posted, so there is no reported denominator or analysis set to evaluate. Consequently, the handling of missing observations, multiplicity, and analysis populations cannot be assessed from the registry record.
11. What the Result Does, and Does Not, Mean
The registry record describes an imaging evaluation in which QTI and MRI interpretations are counted for patients at high lifetime risk of breast cancer. It identifies the positive-finding count as the primary outcome and notes that imaging features and BI-RADS scores are recorded. This establishes what the study intended to measure, but the primary outcome results are not reported in the registry record.
Accordingly, the record does not show whether QTI and MRI produced the same or different numbers of positive findings, nor does it provide uncertainty around any comparison. It does not establish whether the modalities have similar diagnostic accuracy, because the outcome count alone is not a comparison against confirmed disease status. The record mentions a planned comparison with histopathologic diagnosis if biopsies are obtained, but does not report biopsy or pathology results.
The study’s single-group structure and the registry’s warning that the arms are not a like-for-like control comparison are important when interpreting any comparison of modality findings. The interpretation totals relate to both modalities in the same study population, not to separately randomized groups. General statistical interpretation should account for that relationship, but the analysis method is not reported.
The listed zero adverse-event counts should not be generalized into a claim that QTI caused no harm. They describe entries in the adverse-event fields; details on ascertainment and safety analysis are not reported. Overall, the record documents the study’s purpose and outcome definition but does not provide results sufficient to judge differences, diagnostic performance, precision, or safety.
12. Why This Trial Matters Statistically
This study raises a useful statistical question about comparing imaging interpretations within a high-risk screening population. The stated design produces observations for both MRI and QTI in the same patients, with each breast interpreted separately. Such data can be informative because modalities are evaluated in a shared study population, but the paired and potentially clustered structure must be represented when estimating uncertainty. The registry does not report the analysis method, making that an important point for interpreting any eventual comparison.
The outcome also highlights the distinction between imaging yield and diagnostic accuracy. A count of positive findings describes what the interpretations identify. It does not by itself indicate how many findings correspond to disease. The planned relationship to histopathologic diagnosis, if biopsies are obtained, is therefore relevant to diagnostic interpretation, yet biopsy and pathology results are not reported in the registry record.
For biostatisticians and clinical researchers, the record illustrates why an outcome definition and design description are not substitutes for results and analysis details. Interpretation requires the counts, an appropriate uncertainty estimate, the method used to account for paired readings, and information on the reference standard and missing observations. Those details are not reported. The record also cautions against treating this single-group evaluation as a randomized control comparison.
Because the primary results are absent, the statistical importance lies in clarifying what evidence would be needed to assess the study’s question, rather than drawing a conclusion about which modality yields more findings or performs better. The registry record does not support such a conclusion.
13. 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 primary limitation for interpreting this trial is that outcome results and statistical analyses are not reported in the registry record. The number of positive findings by modality, any estimated contrast, and uncertainty around that contrast are unavailable. The registry’s completed status does not resolve this reporting gap.
The design is listed as single-group, with no masking and no randomized allocation. The record explicitly cautions that the arms are not a like-for-like control comparison. The modality interpretations are described within the same patient group, but the analysis method for paired or clustered observations is not reported. This limits assessment of whether statistical uncertainty would appropriately reflect the data structure.
The primary outcome counts imaging findings rather than confirmed disease. Although the description states that findings will be compared with histopathologic diagnosis if biopsies are obtained, biopsy uptake, pathology results, and diagnostic performance measures are not reported. The operational definition of a positive finding and the handling of multiple findings within an interpretation are also not detailed in the registry record.
Eligibility details, participant characteristics, missing-data procedures, analysis populations, and the study’s own sample-size justification are not reported in the registry record. Adverse-event fields contain zero counts, but the record does not provide enough information about safety ascertainment to interpret those entries as evidence of no events. These limitations restrict conclusions about efficacy, diagnostic accuracy, precision, and safety.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer — NCT07216274.
- Registry record last updated 2026-08-20; status last verified 2026-08.
- Results first posted 2026-08-20.
- 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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17. Record Summary
NCT07216274 is a completed Mayo Clinic study of quantitative transmission imaging compared with MRI as supplemental screening for patients at high lifetime risk of breast cancer. The registry lists 26 enrolled patients, a single-group design, no masking, and no randomized allocation. Patients in the Screening (QTI) group undergo ultrasound imaging with a QT Ultrasound Breast Scanner; questionnaire administration is also listed.
The primary outcome counts positive findings from baseline MRI and QTI interpretations. Each breast is interpreted separately, yielding 52 interpretations for each modality. Findings are to be characterized by imaging features, size, location, and BI-RADS score; comparison with histopathology is described if biopsies are obtained.
The study started on 2025-07-31 and primary completion is recorded as 2025-10-20. The registry lists no statistical analyses, and primary outcome results are not reported in the registry record.