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 Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer (NCT03560102), a na na study. The primary outcome is Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03560102 |
| Phase | NA |
| Condition | Breast Cancer, Invasive Ductal |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kantonsspital Winterthur KSW |
| Results posted | Yes |
2. Clinical Question
The study asked whether MRI could assess the quantitative treatment effect of MR-guided high-intensity focused ultrasound by comparing imaging with the pathological specimen after surgical resection. Its stated focus was the volume of necrosis, using histopathology as the reference method. The registry describes a single-center, single-arm, non-randomized study of people with invasive ductal breast cancer who were scheduled for lumpectomy or mastectomy.
Population
Patients with breast cancer, listed in the registry under Breast Cancer, Invasive Ductal, and scheduled for surgical resection. The registry enrollment is 1.
Intervention
Philips Sonalleve® MR-HIFU Breast Therapy System before planned surgery, in a treat-and-resect model.
Comparator
No separate treatment or control group is listed. Histopathological analysis of the resected specimen is the reference method for comparison with MRI.
Primary question
How closely does MRI assessment of the volume of necrosis correspond with histopathology at the Day 14 endpoint?
The clinical question is therefore about measurement and correspondence between imaging and tissue assessment, rather than a comparison of treatment groups. The registry record does not report the observed MRI measurement, histopathological measurement, or their correlation. It also does not report whether surgery and both assessments were completed for the enrolled participant. The stated objective describes what the study set out to evaluate; it is not itself evidence of an observed result.
3. Trial Design
The registry identifies NCT03560102 as a single-center, single-arm, non-randomized trial. Its official title also describes it as a single-center, single-arm study. Allocation is listed as NA and masking as none. There is no randomized allocation and no parallel control arm described, so the study is not designed as a like-for-like comparison between two groups.
The intervention was the Philips Sonalleve® MR-HIFU Breast Therapy System, classified as a device. The planned approach was to treat patients before surgical resection, described as a treat-and-resect model. The arm description refers to patients scheduled for lumpectomy or mastectomy. Histopathological examination of the surgical specimen was intended to serve as a reference against which MRI could be assessed.
The listed condition is Breast Cancer, Invasive Ductal. The sponsor is Kantonsspital Winterthur KSW. The recorded study start is 2020-01-13, and primary completion is 2020-02-05. The status is terminated. Enrollment is 1. The registry does not report why the study was terminated, nor does it provide a termination date. A status label alone does not establish the reason for termination or whether all planned assessments took place.
The phase is listed as NA. The record does not report a control condition, a randomization procedure, or masking beyond the designation of none. It also does not report a detailed schedule for treatment, imaging, surgery, or specimen review beyond the primary endpoint timeframe of Day 14. With a single arm, the primary statistical question concerns agreement or association between two measurement methods, not a treatment effect relative to an untreated or alternative-treatment group.
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: Due to difficulties in recruitment only 2 patients were screened for inclusion and only 1 patient met inclusion criteria and was enrolled in the study.
Overall Study
| Stage | MR-HIFU Treatment |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| 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 | MR-HIFU Treatment |
|---|---|---|
| Participants analysed | 1 | |
| Age, Continuous | years | 66 (SD 0) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Switzerland | participants | 1 |
| Height | cm | 163 (SD 0) |
| Weight | kg | 65 (SD 0) |
6. Primary Endpoint
The registry lists the primary outcome as Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method), measured over Day 14.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of histopathological result |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled as the accuracy of MRI for assessing quantitative treatment success, with correlation against histopathological analysis as the reference method. The stated quantity of interest is the volume of necrosis. The unit is described as percentage of histopathological result, the summary parameter as a mean, and the dispersion as a standard deviation. The timeframe is Day 14.
Comparing MRI with a pathological specimen addresses whether an imaging assessment reflects the tissue finding after treatment and resection. A reference method gives the comparison a clinical measurement target; it does not by itself establish that the imaging method is accurate. The registry record does not report the actual MRI or histopathology values, a correlation estimate, a confidence interval, or a test result. It also does not explain in further detail how the percentage is defined or how measurements were paired.
General: Correlation describes how two measurements vary together. A strong correlation does not necessarily mean the measurements are numerically interchangeable: they can move together while differing systematically in scale or level. Assessment of agreement may therefore require information beyond a correlation coefficient. The registry record names correlation as the comparison but does not report additional agreement methods. Without observed endpoint data, the measurement question can be described, but its empirical answer cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the purpose and structure of the investigation, but it does not report a primary endpoint result. In particular, there is no MRI-to-histology correlation estimate, mean, standard deviation, confidence interval, or p-value in the registry information. The description of the endpoint is not a finding. It identifies the intended comparison of MRI assessment with histopathology for volume of necrosis at Day 14.
Enrollment is 1, and the study is marked terminated. Those details constrain what can be concluded from the registry entry, but they do not explain why the trial ended or whether any measurements were collected. The record does not report completion of treatment, surgery, MRI assessment, pathological assessment, or endpoint analysis for the enrolled participant. Thus, it is not possible to determine from the record whether the primary question was answered, whether the endpoint was evaluable, or what the observed correspondence was.
The design is single-arm and non-randomized. Its histopathology comparison is a comparison between measurement methods within the planned treat-and-resect approach; it is not a control group comparison. There is no basis in this record to estimate a contrast between MR-HIFU and another treatment, or to attribute a clinical outcome to the device. The stated objective concerns evaluation of imaging against a tissue reference.
General: Precision describes how much uncertainty surrounds an estimate. A confidence interval, when reported, communicates a range of values compatible with the data and analysis assumptions. For a correlation or other continuous endpoint, a point estimate alone would not convey the same information about precision. No such estimate or interval is reported in the registry record, so the strength and precision of any MRI-to-histology relationship cannot be evaluated.
The adverse event entry lists one participant at risk in the MR-HIFU treatment group and zero participants affected for serious events, other events, and deaths. These are registry counts, not a substitute for a reported endpoint result. They should be read within the context of the small recorded enrollment and the absence of detail about ascertainment, observation time, or event definitions. The record does not list serious adverse event terms.
Overall, the posted registry information supports a description of the intended measurement study and its limited recorded enrollment, not an estimate of efficacy or diagnostic performance. The absence of a reported result is not evidence that MRI did or did not correspond with histopathology. The reason for termination and the availability of any unposted analyses are not reported in the registry record.
9. Statistical Methods Explained
The statistical information in the registry is limited. It describes a continuous primary outcome, its intended summary as a mean with standard deviation, and a correlation question involving MRI and histopathology. The record reports no analyses. The concepts below explain how such methods are generally interpreted; they do not describe analyses confirmed to have been conducted in this study.
What does a mean and standard deviation describe?
General: A mean summarizes the central level of a continuous measurement by averaging observed values. A standard deviation describes how dispersed those values are around the mean. Together, they can convey a typical level and the spread of observations, but they do not show the full shape of a distribution or identify unusual observations. Their usefulness depends on having observations to summarize and on the measurement being defined consistently.
The registry identifies the primary outcome parameter as MEAN and its dispersion as Standard Deviation. It does not provide the corresponding numerical result or explain in detail how the percentage of histopathological result is derived. Consequently, these labels describe the planned form of reporting, not an available estimate. With enrollment of 1, a group-level estimate of variability would also be difficult to interpret as a description of a broader population; the registry does not report whether any endpoint measurements were available.
What does correlation tell a reader?
General: Correlation summarizes the direction and strength of a relationship between paired measurements. In this setting, the intended pair is MRI assessment and histopathological assessment of necrosis volume. Correlation can indicate whether higher values by one method tend to accompany higher values by the other. It does not, by itself, establish that the methods yield similar numerical values or that one method can replace the other.
For a complete interpretation, readers would need the estimate, its uncertainty, and information about the measurements and analysis population. A confidence interval is generally used to communicate the uncertainty around an estimate under the analysis assumptions. Neither a correlation estimate nor a confidence interval is reported in the registry record. The record also does not report an agreement analysis, a prespecified threshold, or a definition of what degree of correspondence would count as acceptable.
Why does the reference method matter?
General: A reference method provides a comparator for evaluating another measurement method. Here, the endpoint description identifies histopathological analysis as the reference method and MRI as the method being assessed. The choice makes the intended question clear, but interpretation still depends on how both measurements are obtained, whether they refer to comparable tissue volumes, and how the comparison is analyzed. Those procedural details are not reported in the registry record.
The clinical design is single-arm, but the measurement comparison is not a comparison between independent treatment arms. It is an intended comparison of methods. That distinction matters: a correlation between MRI and histopathology would address whether measurements track together, not whether MR-HIFU performs better than another treatment or changes outcomes relative to a control group.
What do the analysis and planning details establish?
The registry lists zero analyses. It therefore does not identify a reported statistical analysis of the primary endpoint. There is no documented estimate, hypothesis test, confidence interval, or adjusted analysis to interpret. The record does not report an analysis population, a missing-data method, or a plan for handling measurements that could not be obtained.
The stated sample-size assumptions describe a planning illustration, not the trial's own design: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Those assumptions are generic inputs for an illustration and do not match the recorded single-arm design as a randomized two-arm comparison. The registry enrollment is 1. Such illustrations are not observed power and do not establish that the study was sized according to those assumptions. The registry record does not report the trial's sample-size justification.
In general, power planning concerns the chance that a specified analysis will detect an effect of a chosen size under stated assumptions. It is a design-stage concept, not a measure of what a completed study found. A planning calculation based on an observed effect is especially distinct from an original protocol justification. No numerical planning output is stated in the registry information, and none can be used to infer a primary endpoint result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary endpoint concerning MRI assessment and histopathological analysis, and identifies a secondary outcome as Assessment of Treatment Efficacy. It records three outcome measures and zero analyses. The available information does not describe how many hypotheses were formally tested, which outcomes were included in an analysis, or whether any multiplicity adjustment was planned. A multiplicity strategy is not reported in the registry record.
General: When an analysis tests several outcomes or hypotheses, the chance of at least one apparently notable result can increase if each test is interpreted separately. Prespecified priorities and multiplicity procedures can help clarify which results are confirmatory and how uncertainty should be read. Without a reported analysis plan or results, no conclusion can be drawn about how this study addressed that issue.
Missing-data handling is not reported in the registry record. The entry does not state whether MRI or pathology measurements were missing, how incomplete assessments would be treated, or whether a participant without both measurements would be excluded from the endpoint analysis. It does not identify an analysis population, such as all enrolled participants or those with evaluable paired assessments. Enrollment of 1 does not establish whether the primary endpoint was measured for that participant.
These omissions limit interpretation rather than demonstrating that missing data or multiplicity affected the study. The record does not provide enough information to assess either issue empirically. The analysis population, missing-data rules, multiplicity plan, and any resulting sensitivity analyses 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 |
|---|---|---|---|
| MR-HIFU Treatment | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MR-HIFU Treatment | 0 of 1 |
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 |
|---|---|
| MR-HIFU Treatment | 0 of 1 |
The registry's adverse event entry lists the MR-HIFU Treatment group with one participant at risk. It records zero affected participants for serious adverse events, zero affected participants for other adverse events, and zero deaths. No serious adverse event terms are listed.
These are counts as recorded, not evidence that events were impossible or that safety was established. In general, an observed count of zero means that no affected participants were recorded in the specified category; it does not show what might occur in a larger population or under different observation conditions. Interpretation also depends on how events were defined, collected, and monitored.
The registry record does not report the safety observation period, event definitions, collection methods, or whether the listed at-risk participant completed the planned treatment and follow-up. It also does not give further detail about the zero counts. Because enrollment is 1, the safety information is especially limited in scope. The counts should be read as registry entries for this study, not as a comparative estimate or a broad characterization of risk.
12. What the Result Does, and Does Not, Mean
The study's stated aim was to evaluate MRI as a method for quantitative assessment of treatment success by comparing MRI with histopathology after resection. More specifically, it focused on the correspondence between the methods for volume of necrosis, with a Day 14 timeframe. That is a measurement question within a planned treat-and-resect approach.
The registry record does not report the primary endpoint result. It therefore does not establish how closely MRI and histopathology corresponded, whether the imaging assessment was accurate, or how precise any estimate was. The objective and endpoint wording describe the intended evaluation; they are not a reported finding. The record also does not report whether the planned procedures and endpoint measurements were completed.
The design has no separate comparator arm. As a result, it cannot provide a randomized estimate of the effect of MR-HIFU relative to another treatment. Its purpose, as described, is not a between-treatment comparison but a comparison between an imaging assessment and a pathological reference. Even a reported correlation would need to be interpreted as a measure of association, not automatically as proof that the measurements agree closely enough to be interchangeable.
The registry records enrollment of 1 and a terminated status. It does not state why the study was terminated, whether termination occurred before or after planned assessments, or whether analyses exist outside the registry entry. The adverse event counts are zero in the recorded categories, but that small recorded experience cannot support broad conclusions about safety.
General: A study result is most informative when the estimate is accompanied by uncertainty and the analysis population and methods are clear. Here, the registry record does not report these endpoint details. The appropriate interpretation is therefore bounded: the intended question and design can be described, but the empirical answer cannot be determined from the registry information. Neither a positive nor a negative conclusion about MRI performance follows from an unreported result.
13. Why This Trial Matters Statistically
This study is statistically distinctive because its stated primary question concerns correspondence between two ways of assessing tissue response, rather than a contrast between treatment groups. MRI was to be compared with histopathology, which the registry identifies as the reference method. Recognizing that distinction prevents a measurement study from being interpreted as a randomized treatment-effect trial.
The endpoint wording also raises an important general measurement issue. Correlation and agreement are related but not identical concepts. Correlation concerns whether measurements vary together; agreement concerns how closely their values match. A method can show association without producing values that are interchangeable with its reference. The registry names correlation, but does not report an estimate or additional agreement methods, so the intended statistical question is clearer than its empirical answer.
The recorded single-arm design, enrollment of 1, and terminated status make the absence of a reported endpoint result consequential. Without paired observations and an estimate of uncertainty, readers cannot judge the strength or precision of the imaging-to-pathology relationship. The record also does not describe an analysis population or missing-data approach, details that would matter if either assessment were unavailable.
General: Transparent reporting separates a study's objective, its planned methods, and its observed findings. This record allows the objective and broad design to be identified, while leaving the primary numerical finding and the reason for termination unreported. That distinction is useful for statistical reading: a clearly defined research question should not be mistaken for evidence that it has been answered.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial is that the registry record does not report a primary endpoint result. It gives no numerical MRI or histopathology measurements, correlation estimate, uncertainty interval, or statistical test. The reader therefore cannot assess either the direction or precision of the intended relationship.
Enrollment is 1, and the status is terminated. The reason for termination, the termination date, and whether the planned assessments were completed are not reported in the registry record. The record does not establish whether the enrolled participant received treatment, underwent resection, or had paired MRI and pathology measurements available for analysis.
The study is single-center, single-arm, and non-randomized, with no separate control group listed. This design addresses a method-comparison objective as described, not a treatment contrast. The endpoint description names correlation but does not report additional methods for assessing agreement, nor does it give operational detail for the percentage measure. A correlation result, if available, would not on its own demonstrate measurement interchangeability.
The registry lists zero analyses and does not report an analysis population, missing-data strategy, multiplicity plan, or sample-size justification. These details are needed to understand how the endpoint was analyzed and how robust an estimate might be. The planning assumptions describe an illustration rather than the study's own design and should not be treated as evidence of observed power.
The safety entry contains zero affected participants in the listed categories, but the safety observation period and event-collection methods are not reported. With the limited recorded enrollment, those counts cannot establish the frequency of events beyond the registry entry. The record does not explain whether missing results reflect noncompletion, nonreporting, or another circumstance.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer — NCT03560102.
- Registry record last updated 2021-10-22; status last verified 2021-09.
- Results first posted 2021-10-22.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03560102 is a terminated, single-center, single-arm, non-randomized study sponsored by Kantonsspital Winterthur KSW. It evaluated the Philips Sonalleve® MR-HIFU Breast Therapy System before planned breast cancer surgery in a treat-and-resect model. The listed condition is Breast Cancer, Invasive Ductal; enrollment is 1. The recorded start date is 2020-01-13, and primary completion is 2020-02-05.
The primary endpoint concerned MRI assessment of quantitative treatment success, compared with histopathology as the reference method for volume of necrosis at Day 14. The registry record does not report a primary endpoint result, analyses, or the reason for termination. It lists zero affected participants for serious and other adverse events and zero deaths, with one participant at risk in the treatment group. The safety observation details are not reported in the registry record.