MR Characterisation/Localisation of Breast Cancer
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer|
- Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions [ Time Frame: 4 years ] [ Designated as safety issue: No ]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.
- Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567137
|Royal Marsden NHS Foundation Trust|
|Sutton, Surrey, United Kingdom, SM2 5PT|