NCT00706485终止不适用
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use
研究概览
简要总结
The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque applicator. The Y-90 plaque application is designed to deliver high doses of radiation to tumors in the spine that involve dura (the tough outer layer of the spinal cord). Tumors in the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque applicator is a special technique used to deliver the radiation dose to the tumor cells and avoid the spinal cord.
详细描述
- The surgeon will remove the participants tumor from the outer layer of the spinal cord (dura). The Y-90 applicator and a "dummy" applicator will be brought to the surgery table in a protected container. A "dummy" applicator is the same size and shape as the Y-90 plaque applicator but does not contain radioactive plaque. The "dummy" applicator will be placed on the participants dura to make sure it fits properly, then it will be removed. The working Y-90 applicator will be placed on the dura for 10-17 1/2 minutes and then be removed.
- External beam irradiation is a type of high-energy radiation used to kill cancer cells and shrink tumors. This radiation will be given to the participant only if they have not had it prior to the study.
- After the treatment, participants will be asked to return for a follow-up visit 6 weeks, 3 months, every 6 months thereafter for 4 years, then annually to year 10. At these visits, they will have the following: physical examination; recent medical history; MRI or CT scan (twice each year) and; chest x-ray or chest CT (twice each year).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of malignant tumor involving spine with extraosseous extension or arising in paraspinal soft tissues with tumor involving or abutting the dura. Patients with a limited metastatic disease and tumor involving the spine or paraspinal soft tissues and who are judged to benefit from surgery will also be eligible.
- •Lesion may be primary or recurrent after prior surgery
- •No clinical, radiographic or other evidence of distant metastatic tumor
- •Fit for receiving the planned radiation dose to the affected site. No known genetic disease or medical condition associated with an abnormal radiation sensitivity.
- •18 years of age or older
- •KPS of 70 or greater (excluding consideration of poor function due to the local growth or systemic metabolic effects of the tumor
排除标准
- •Disease/conditions characterized by high radiation sensitivity
- •Pregnancy
- •Evidence of cord/cauda malfunction for causes other than effect os local tumor growth or due to metabolic effects of tumor
结局指标
主要结局
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use
时间窗: At time of procedure
次要结局
- Number of Participants With Local Control(at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10)
- Marginal Failure.(up to 10 years)
研究者
Tom DeLaney, MD
MD
Massachusetts General Hospital
研究点 (2)
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