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临床试验/NCT01601691
NCT01601691已完成不适用

Protection of Rectum From High Radiation Doses

University of Oulu1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Spacer Volume Half Life

研究概览

简要总结

The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.

详细描述

Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited. Diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 76 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer

排除标准

  • •not willing to participate this study

研究组 & 干预措施

Spacer

Experimental

Subjects with spacer injection

干预措施: DuraSeal (Device)

结局指标

主要结局

Spacer Volume Half Life

时间窗: 1 day, 4 weeks, 8 weeks, up-to 16 weeks

Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.

次要结局

  • Side Effects(1 day, 4 weeks, 8 weeks, 12 weeks)
  • Rectum Radiation Dose(1 day, 4 weeks, 8 weeks)

研究者

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

Markku Vaarala, MD, PhD

MD, PhD

University of Oulu

研究点 (1)

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