Clinical trial · Observational
MR Characterisation/Localisation of Breast Cancer
Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision. Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions
- timeFrame
- 4 years
- description
- Sensitivity of the MR technique in detecting histopathologically-identified multifocal/centric pre-invasive/invasive disease will be calculated (with 95% confidence intervals)from positive or negative correlates.
Secondary outcomes (1)
- measure
- Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.
- timeFrame
- 4 years
- description
- Distance \& distribution of lesions from reference tumour will be plotted and correlated with distances and signal characteristics seen on multifunctional MR. Pre-op MRI volume will be plotted against histopathological dimensions and examined for agreement between the two methods. Paired Wilcoxon signed-rank tests will be used to test for systematic differences between MRI and pathology measurements.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven invasive ductal carcinoma of the breast * Unifocal disease * Patient proceeding to mastectomy Exclusion Criteria: * Multifocal disease * Previous surgery to ipsilateral breast * Neoadjuvant chemotherapy * Ferromagnetic implants * Claustrophobia * Cup size DD or greater
References
Publications (0)
Data not yet available