Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
研究概览
简要总结
The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET tracer, immunohistochemical analysis and clinical parameters.
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
- •adults aged between 18 and 70 years
- •must have operable grade II, III or IV glioma, recurrent high grade glioma or brain metastases
- •KPS >= 70%
- •must have the understanding and ability to sign an informed consent document
- •must have adequate liver and kidney function
- •be male or non-pregnant, non-lactating females
- •patients who are fertile must agree to use an effective method of contraception during participation in the study
- •the following laboratory results : absolute neutrophil count >= 1500 cells/µl, platelet count >= 100000 cells/µl, SGOT <= 2.5 x ULN, serum creatinine <= 1.5 x ULN.
排除标准
- •contraindication to surgery
- •concomitant radio-, chemo-, or immunotherapy
- •history of significant dementia
- •known diagnosis of Human Immunodeficiency Virus (HIV) infection
- •patient with hepatitis B or C
研究组 & 干预措施
FLT-PET imaging
Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
干预措施: FLT-PET imaging (Other)
结局指标
主要结局
To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
时间窗: Day 10
次要结局
- To define relations between [18F]FLT uptake and clinical, histological and radiological parameters(Day 90)
- To define relations between [18F]FLT uptake and patient survival(J90)
- To compare the efficiency of [18F]FLT with [11C]MET(Day 15)