Early Assessment of Treatment Response Using Functional Diffusion Mapping
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in diffusion MRI measurements
研究概览
简要总结
This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
详细描述
This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate cancer.
- •Evidence of metastatic disease by bone scan.
- •Patients must be initiating systemic therapy for metastatic disease.
- •New D2 disease beginning therapy with androgen deprivation.
- •CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
- •Patients must be willing to provide the blood samples for the correlative markers.
- •Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes.
- •Life expectancy of 12 weeks or greater.
- •All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.
排除标准
- •Contraindication to MRI imaging.
- •Patients who require sedation with general anesthesia to undergo MRI imaging.
- •Weight greater than 275 pounds.
结局指标
主要结局
Change in diffusion MRI measurements
时间窗: Baseline, 2 weeks and 9-12 weeks
Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.
次要结局
- Change in units/L of CK18Asp306(Baseline, 2 weeks and 9-12 weeks)
- Change in levels of bone turnover markers(Baseline, 2 weeks and 9-12 weeks)