Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
|
at the time of each procedure.
Other Names:
removal of breast tumor or removal of the entire breast in which the tumor is located
Other Names:
Prior to initiation of treatment
Other Names:
After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
Other Names:
Prior to initiation of treatment
Other Names:
|
|
No Intervention: Healthy volunteers
Women without breast cancer undergo DCE-MRI and MRS.
|
What is the study measuring?
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
Time Frame: At time of breast surgery
|
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
Time Frame: After the last scan
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC BRE 0358
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-BRE-0358
- VU-VICC-IRB-030472
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