跳至主要内容
临床试验/NCT02559401
NCT02559401已完成不适用

Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation

Abramson Cancer Center at Penn Medicine1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年6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
68
试验地点
1
主要终点
Number of subjects providing completion of the neurocognitive battery

研究概览

简要总结

Currently, standard-of-care tractography is based on information obtained from diffusion tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary objective of the proposed study is to determine the ability of msHARDI-based tractography to discern fibers in edematous brain regions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •brain lesions, including but not limited to tumors, epileptic foci, and vascular abnormalities, in or around eloquent brain regions (i.e., motor, language);
  • •clinical need for pre-operative 'advanced imaging' (which includes conventional DTI);
  • •age between 18-80 years of age;
  • •male or female gender. Eloquent regions include: Temporal and frontal lobes (speech/language); bilateral occipital lobes (vision); bilateral parietal lobes (sensation); and bilateral motor cortex (movement).

排除标准

  • •a contraindication for obtaining an MRI scan (e.g. implanted devices, retrained foreign body)
  • •pregnancy
  • •absence of the capacity to make medical decisions or provide informed consent.

结局指标

主要结局

Number of subjects providing completion of the neurocognitive battery

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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