Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage Change in Measure of FLT Flux
研究概览
简要总结
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).
II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.
III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).
SECONDARY OBJECTIVES:
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
- •Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging
- •Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined
排除标准
- •Inability to provide informed consent
- •Pregnancy
- •Inability to lie still for the imaging study
- •Weight over 350 lbs.
结局指标
主要结局
Percentage Change in Measure of FLT Flux
时间窗: Baseline to up to 1 year after completion of treatment
The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.
Percentage Change in Measure of Reflecting Transport
时间窗: Baseline to up to 1 year after completion of treatment
The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).
Percentage Change in Measure of Standard Uptake Value
时间窗: Baseline to up to 1 year after completion of treatment
The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.
Survival
时间窗: Up to 7 years
Time from study entry to death will be recorded
Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria
时间窗: Up to 7 years
This is clinical response as assessed at physician discretion using standard of care criteria.
次要结局
未报告次要终点