Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment. PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.

Detailed Description
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OBJECTIVES: To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology. To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery. OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy. Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies. Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings. The study interventions are discontinued after definitive surgery is performed. PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.

Official Title
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Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: proteomic profiling
* Procedure: lumpectomy or mastectomy
* Procedure: dynamic contrast-enhanced magnetic resonance imaging
* Procedure: histopathologic examination
* Procedure: magnetic resonance spectroscopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Women with breast tumors planning to undergo surgical resection Healthy volunteers, including any constitutionally healthy female with no history of breast cancer Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Not acutely ill No non-magnetic resonance-compatible ferromagnetic materials present in the body PRIOR CONCURRENT THERAPY: Prior chemotherapy and/or radiotherapy allowed

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with breast cancer<br>Patients undergo DCE-MRI and MRS prior to their breast cancer surgery. | Genetic: proteomic profiling<br>* at the time of each procedure.<br>* Other names: proteomic analysis;Procedure: lumpectomy or mastectomy<br>* removal of breast tumor or removal of the entire breast in which the tumor is located<br>* Other names: None noted;Procedure: dynamic contrast-enhanced magnetic resonance imaging<br>* Prior to initiation of treatment<br>* Other names: DCE-MRI;Procedure: histopathologic examination<br>* After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer<br>* Other names: Not noted;Procedure: magnetic resonance spectroscopy<br>* Prior to initiation of treatment<br>* Other names: MRS;|
| No Intervention: Healthy volunteers<br>Women without breast cancer undergo DCE-MRI and MRS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer | Imaging and spectroscopic studies are performed before surgery. After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient's tissue. | At time of breast surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer | Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy. | After the last scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer