Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief summary
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
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.
Interventions
GENETICproteomic profiling
at the time of each procedure.
PROCEDURElumpectomy or mastectomy
removal of breast tumor or removal of the entire breast in which the tumor is located
PROCEDUREdynamic contrast-enhanced magnetic resonance imaging
Prior to initiation of treatment
PROCEDUREhistopathologic examination
After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
PROCEDUREmagnetic resonance spectroscopy
Prior to initiation of treatment
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer | 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. |
Outcome results
None listed