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临床试验/NCT01089868
NCT01089868已完成不适用

Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis

Ludwig-Maximilians - University of Munich3 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
3
主要终点
Overall Survival

研究概览

简要总结

The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neuroradiologically suspected Glioblastoma multiforme
  • histological verification will be obtained either by microsurgery or by stereotactic biopsy. The neuropathological diagnosis will be verified by a reference neuropathologist
  • patients will undergo radiochemotherapy subsequent to surgical procedure
  • patients older than 18 years
  • Karnofsky Performance Score >=70
  • pregnant or nursing female patients will not be included in this study
  • safe contraceptive methods during the radiochemotherapy and chemotherapy

排除标准

  • patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
  • patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
  • medical history of a metastatic brain disease
  • patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.

结局指标

主要结局

Overall Survival

时间窗: 46 months

次要结局

  • Progression Free Survival(46 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bogdana Suchorska

PI

Ludwig-Maximilians - University of Munich

研究点 (3)

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