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临床试验/NCT00603694
NCT00603694已完成不适用

Hippocampal Radiation Exposure and Memory: A Pilot Study

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2007年9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
1
试验地点
1

研究概览

简要总结

Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.

In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients planned for radiosurgery for benign disorders (Groups 1&2).
  • Patients planned for prophylactic cranial irradiation (Group 3)

排除标准

  • Previous cranial radiation
  • Severe psychiatric disorder
  • Severe cognitive or memory impairment (MMSE < 21)
  • Non-English speaking, which will potentially make memory testing difficult and unreliable.
  • Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
  • Patients on steroid medications.
  • Left hand dominant patients
  • Dose exposure to left hippocampus >0.5Gy and <2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure >0.5 Gy and < 2Gy following baseline memory testing.
  • Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures
  • Previous brain surgery within one year prior to radiosurgery
  • Pregnant women

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Hippocampal Radiation Exposure and Memory | 临床试验