跳至主要内容
临床试验/NCT02978911
NCT02978911招募中不适用

Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Correlation between the expected and the real position of the selected cranial nerve

研究概览

简要总结

Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.

Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who present a skull base tumor that requires surgical removal
  • Patients adult, informed and agreed

排除标准

  • Pregnant women
  • Patients under 18 years old, unable to legally consent

结局指标

主要结局

Correlation between the expected and the real position of the selected cranial nerve

时间窗: at 3 months

Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.

次要结局

  • postoperative cranial nerve palsy(at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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