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Sponsored by: |
Royal Marsden - Surrey |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602316 |
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.
Condition | Intervention |
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Breast Cancer |
Drug: gadolinium-chelate Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 20 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Contact Person 44-208-661-3392 annakirby@doctors.org.uk |
Investigator: | Anna Kirby | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000581176, RMH-CCR2995 |
Study First Received: | January 16, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00602316 |
Health Authority: | Unspecified |
invasive ductal breast carcinoma stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Carcinoma, Ductal, Breast Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site |