Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change from pre- to posttreatment
研究概览
简要总结
The purpose of this study is to see if PET/CT scans that use a radioactive substance called [18F] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive substances are used with PET/CT scans to "see" cancer cells, and are also called radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard clinical scan and is commonly used. The investigators would like to know if there is any evidence of early treatment response by obtaining FLTPET/ CT scans before and after treatment.
详细描述
This protocol is an "umbrella" or "companion" protocol to be used in conjunction with other protocols that are evaluating treatment response in solid or hematologic malignancies. The aim of this protocol is to determine if PET imaging with the proliferation marker 18FFLT can monitor changes in FLT uptake parameters, in particular changes in the standardized uptake value (SUV), within tumor target lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with histologically-confirmed (confirmation done at MSKCC) malignancies.
- •Patients who have consented to a therapeutic protocol for the treatment of their cancer.
- •Patients must be ≥ 18 years old.
排除标准
- •Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- •Women who are pregnant or breast-feeding.
结局指标
主要结局
change from pre- to posttreatment
时间窗: 4 years
We will describe the distribution of the change and explore if it is associated with the findings of standard-of-care imaging such as FDG-PET or CT/MRI using rank based methods such as Spearman correlation and the signed-ranks test. In addition we will also explore the value of the change in the FLT metrics in predicting the clinical outcome using logistic regression (for response) and proportional hazards regression (for progression and survival).
次要结局
未报告次要终点