Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: gadolinium-chelate
* Procedure: conventional surgery
* Procedure: magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gadolinium-chelate|nan|
|Procedure: conventional surgery|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor |  |  | 
| Assessment of distribution of satellite lesions in relation to index tumor |  |  | 
| Correlation between histopathological characteristics and signal changes on multifunctional MR |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive ductal breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer