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临床试验/NCT00841685
NCT00841685已完成不适用

The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年12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
25
试验地点
2
主要终点
Acute toxicity after implantation of the fiducial gold markers

研究概览

简要总结

Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • histological proven adenocarcinoma of the prostate
  • T1-T4 tumors
  • Radiotherapy as primary therapy +/- androgen deprivation
  • Presence of an intraprostatic lesion (IPL) on MRI/MRS
  • Presence of an intraprostatic lesion (IPL) on ultrasound

排除标准

  • Other primary tumor, except non-melanoma skin cancer
  • No written informed consent

结局指标

主要结局

Acute toxicity after implantation of the fiducial gold markers

时间窗: 1 week after implantation

次要结局

  • Feasibility of insertion 1 fiducial gold marker in the intraprostatic lesion combined with extra gold markers in the rest of the prostate upto 3 goldmarkers in total(1 week after implantation)
  • Visualization of the implanted gold markers by ultrasound(After implantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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