NCT01083719Unknown2 期
Phase II Study Comparing FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.
Medanta Institute of Clinical Research0 个研究点目标入组 15 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 主要终点
- Tumor infiltration defined on FDG-PET not determined to MRI
研究概览
简要总结
HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%, a sample size of 15 patients would be accrued in the study.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post operative patients of documented high grade gliomas (grade III and IV)
- •Patients who have not undergone any previous irradiation to brain.
- •Performance Scale as defined by ECOG PS 0-3
排除标准
- •Patients who are diabetic.
- •Patients who are pregnant.
- •Any documented contrast allergy to the agents used for imaging.
- •Patients who are unable to comprehend or cooperate effectively for treatment planning.
结局指标
主要结局
Tumor infiltration defined on FDG-PET not determined to MRI
时间窗: 18 months
次要结局
未报告次要终点
研究者
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