Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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:
- •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
排除标准
- 未提供
研究组 & 干预措施
Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
干预措施: proteomic profiling (Genetic)
Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
干预措施: lumpectomy or mastectomy (Procedure)
Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
干预措施: dynamic contrast-enhanced magnetic resonance imaging (Procedure)
Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
干预措施: histopathologic examination (Procedure)
Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
干预措施: magnetic resonance spectroscopy (Procedure)
Healthy volunteers
Women without breast cancer undergo DCE-MRI and MRS.
结局指标
主要结局
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
时间窗: 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.
次要结局
- Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer(After the last scan)
研究者
A Bapsi Chakravarthy, MD
Associate Professor
Vanderbilt-Ingram Cancer Center