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临床试验/NCT00181350
NCT00181350已完成3 期

Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年11月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.

研究概览

简要总结

This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.

详细描述

Stereotactic conformal radiotherapy (SCRT) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. In the use of stereotactic conformal radiotherapy (SCRT) accuracy is the mainstay for the treatment of brain tumours. The reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose.

This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. The first approach will be based on the BrainLAB thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system.

Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above.

The rationale is to determine the margins to define the planning target volume (PTV), it is necessary to know the set-up accuracy of the immobilization system. An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss.

The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Clinical diagnosis of brain tumor
  • Fractionated stereotactic radiotherapy

排除标准

  • 未提供

结局指标

主要结局

CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.

次要结局

  • No secondary measures.

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other

研究点 (2)

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