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Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
invasive ductal breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Primary Purpose: Diagnostic
Intervention
Name: gadolinium-chelate
Type: Drug
Name: conventional surgery
Type: Procedure
Name: magnetic resonance imaging
Type: Procedure
Name: magnetic resonance spectroscopic imaging
Type: Procedure
Overall Status
Recruiting
Summary
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.
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
OBJECTIVES:
- 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.
- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: DISEASE CHARACTERISTICS:
- 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
- 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
Location
Royal Marsden - Surrey
Sutton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-208-661-3392 - annakirby@doctors.org.uk
Start Date
November 2007
Sponsors
Royal Marsden NHS Foundation Trust
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page