MR Characterisation/Localisation of Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01567137|
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : June 15, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer|
|Study Start Date :||November 2007|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
- Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions [ Time Frame: 4 years ]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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567137
|Royal Marsden NHS Foundation Trust|
|Sutton, Surrey, United Kingdom, SM2 5PT|