The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 18F-clofarabine concentration in cancer tissue
研究概览
简要总结
This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.
OUTLINE:
Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
- •No restrictions based on gender or racial/ethnic background
排除标准
- •Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
结局指标
主要结局
18F-clofarabine concentration in cancer tissue
时间窗: Up to 4 weeks
Change in 18F-clofarabine biodistribution
时间窗: Baseline to up to 4 weeks
For the biodistribution studies, regions of interest will be drawn on images of liver, kidney, bladder, heart, lung and blood pool to obtain regional activity count rates. Standardized uptake values (SUV = count activity per ml within region of interest (MBq-1)/(injected dose \[MBq\]/body weight \[kgx1000\]) will be calculated for different organs and for regions of tumor. Further, regional target to background count activity ratios will be established.
次要结局
未报告次要终点