跳至主要内容
临床试验/NCT01083719
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

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

发起方
Medanta Institute of Clinical Research
申办方类型
Other

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