[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios
研究概览
简要总结
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue.
详细描述
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Drug safety will also be monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma.
排除标准
- •Pregnancy
- •Requirement for sedation
- •Lack of informed consent
研究组 & 干预措施
Phase I
Children, ages 5-15 years with brain tumors
干预措施: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical (Drug)
结局指标
主要结局
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios
时间窗: 15-30 minutes after IV administration
次要结局
未报告次要终点