Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
Recruitment status was: Recruiting
RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may help doctors learn the extent of disease and plan the best treatment.
PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.
Procedure: conventional surgery
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer. A Pilot Observational Study Testing the Accuracy of Multifunctional Magnetic Resonance Techniques in Predicting the Presence, Distribution and Nature of Breast Lesions in Women With Known Breast Cancer|
- Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions [ Designated as safety issue: No ]
- Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor [ Designated as safety issue: No ]
- Assessment of distribution of satellite lesions in relation to index tumor [ Designated as safety issue: No ]
- Correlation between histopathological characteristics and signal changes on multifunctional MR [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- To determine the accuracy of multifunctional magnetic resonance (MR) in detecting, localizing, and characterizing satellite lesions in relation to an index breast tumor in order to improve definition of clinical target volume after local excision.
OUTLINE: Patients receive an injection of gadolinium chelate and undergo multifunctional magnetic resonance (MR) imaging, including dynamic contrast-enhanced MR, hydrogen-MR spectroscopy, and diffusion-weighted MRI, of the ipsilateral breast within 4 weeks before surgery. Patients undergo a mastectomy as planned. The resected specimen is photographed, and a histopathological analysis is performed consisting of the size and grade (if pre-invasive or invasive disease) of each satellite lesion, classification of benign satellite lesions, dimensions of each lesion, distance from the edge of the index tumor to the center of each satellite lesion, and the distance from the center of the surface of the nipple to the center of each lesion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602316
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|OverallOfficial:||Anna Kirby||Royal Marsden NHS Foundation Trust|