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临床试验/NCT03964909
NCT03964909已完成不适用

Resting-State Functional MRI in Glioma Patients Before and After Surgery

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Detectability of language networks

研究概览

简要总结

This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

详细描述

PRIMARY OBJECTIVES:

I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.

SECONDARY OBJECTIVES:

I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.

OUTLINE:

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed brain mass suspected to be gliomas
  • English speaker
  • Right handed
  • Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language
  • No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist
  • Patients who will undergo neurosurgical resection
  • Patients who are on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care
  • Patients who will complete pre- and postoperative neuropsychological testing per standard of care
  • Pregnant women

排除标准

  • Patients with prior radiation or chemotherapy
  • Patients cannot give informed consent
  • Patients cannot undergo MRI and functional MRI examinations

结局指标

主要结局

Detectability of language networks

时间窗: Up to 6 weeks

Will be performed using resting-state-functional magnetic resonance imaging (rs-fMRI). The receiver operating characteristic (ROC) analysis will be carried out to compare the difference between the diagnostic performance of the proposed method and that of the data-driven rs-fMRI method. The study will evaluate the performance of rs-fMRI by comparing with the standard of care intraoperative direct cortical stimulation.

次要结局

  • Changes in resting-state functional connectivity and neuropsychological outcomes(Up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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