MRI Evaluation of Breast Tumor Growth and Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment.
PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
详细描述
OBJECTIVES:
- Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI [DCE-MRI], diffusion-weighted MRI [DW-MRI], and magnetic resonance spectroscopy [MRS]) to characterize breast tumors in women with known or suspected breast cancer.
- Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
- Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
- Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
- Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
- Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.
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
- 否
入选标准
- 未提供
排除标准
- •Children will be excluded from this study.
- •Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)
- •Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.
- •Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
- •Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
- •Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"
结局指标
主要结局
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
时间窗: on-study date and at 6 months, up to 4 years
Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)
次要结局
- Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings(at 6 months)
- Establishment of an imaging data bank(at 6 months)
研究者
A Bapsi Chakravarthy, MD
Professor; Radiation Oncology
Vanderbilt-Ingram Cancer Center