Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
NCT ID: NCT00602316
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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gadolinium-chelate
conventional surgery
magnetic resonance imaging
magnetic resonance spectroscopic imaging
Eligibility Criteria
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Inclusion Criteria
* Biopsy-confirmed invasive ductal carcinoma of the breast
* Unifocal disease as defined by clinical examination, mammography, and ultrasound
* Patient must be proceeding to mastectomy
* Hormone receptor status unknown
* No T4d or multifocal disease (as defined on conventional imaging)
* Index tumor ≤ 4 cm in diameter
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Female
* No claustrophobia
* No cup size of DD or greater
PRIOR CONCURRENT THERAPY:
* No prior surgery to ipsilateral breast
* No prior neoadjuvant chemotherapy
* No prior ferromagnetic implants
18 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Anna Kirby
Role:
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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RMH-CCR2995
Identifier Type: -
Identifier Source: secondary_id
CDR0000581176
Identifier Type: -
Identifier Source: org_study_id