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临床试验/NCT04758104
NCT04758104已完成不适用

Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid for Treatment of Cystic Lesions of the Brain: Open Label Individual Patient (OLIP) Study

David Clarke2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
2
主要终点
Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.

研究概览

简要总结

Neuroepithelial cysts are rare, representing less than 1% of the intracranial cysts. Neuroepithelial cysts, are benign and mostly asymptomatic. These cysts are lined by thin columnar or low cuboidal epithelium. The CSF-like contents of the cyst are due to secretion of the epithelial cyst wall. Although mostly asymptomatic, symptoms can occur when the cyst enlarges; the specific symptoms vary according to the size (mass effect) and location of the lesion. Radioactive phosphorus (32P) and 90yttrium colloid are isotopes that have been used. These are approved in the United States and Europe. 32P is not available in Canada. We want to use 90yttrium colloid. There is evidence in the scientific literature that treatment with 90yttrium colloid injected into the cyst is effective in preventing the cyst from growing, effective in causing the cyst to get smaller and in some cases the cyst disappears.

详细描述

In brief, a single patient has been identified as having a cystic tumor by diagnostic imaging and clinical expertise and based on standards of excellence in clinical care will be offered participation in the study for the intracystic implantation of 90yttrium colloid. This patient will be followed closely for 4 weeks following 90yttrium colloid treatment and then receive standard of care (http://neurosurgery.medicine.dal.ca).

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
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.

时间窗: 1 MONTH

90Yttrium colloid will be inserted into the cyst using neurosurgical techniques.

Shrinkage of cyst

时间窗: 1 Month

Intracystic application of 90Yttrium colloid will result in the shrinkage of the cyst.To estimate the efficacy of intracavitary application of 90Yttrium colloid for the treatment of an adult with a cystic tumor in the brain by a single neurosurgeon.

次要结局

  • PET-CT scan will be used to visualize the yttrium within the cyst.(1 -4 days)

研究者

发起方
David Clarke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Clarke

Neurosurgeon

Nova Scotia Health Authority

研究点 (2)

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