NCT03242824已完成2 期
MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Progression-free Survival
研究概览
简要总结
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
18F-DOPA PET
Experimental
Patients will receive 18FDOPA-PET for radiation treatment planning
干预措施: Fluorine F 18 Fluorodopa (Drug)
18F-DOPA PET
Experimental
Patients will receive 18FDOPA-PET for radiation treatment planning
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
18F-DOPA PET
Experimental
Patients will receive 18FDOPA-PET for radiation treatment planning
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Proportion of Participants With Progression-free Survival
时间窗: up to 3 months
measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls
次要结局
- Quality of Life Brief Fatigue Index (BFI) Change From Baseline(Baseline and 3 months)
- Overall Survival(From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years)
- Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities(up to 2 years)
- Re-operative Count(up to 2 years)
- Quality of Life MDASI-BT Change From Baseline(Baseline and 3 months)
研究者
研究点 (1)
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