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临床试验/NCT06651463
NCT06651463尚未招募不适用

Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Feasibility of recording video of useful quality to determine tissue quality

研究概览

简要总结

The management of many brain pathologies involves obtaining a functional and histological diagnosis and performing neurosurgery when possible. Histological diagnosis makes it possible to differentiate healthy areas from pathological areas. Functional diagnosis allows the identification of brain areas to be spared during neurosurgery in order to avoid any permanent post-operative disability.

The visual analysis of the color and texture of the brain by the trained eye of the neurosurgeon is largely part of his operating practice. It allows it to differentiate between healthy and pathological areas. Likewise, color variations linked to the functional activation of brain areas are sometimes visible to the naked eye. However, this approach is not optimal due to the limits of human vision. It is also very strongly dependent on the experience and expertise acquired by the neurosurgeon. This approach is therefore largely limited in many operating contexts: low visual contrasts, less experienced neurosurgeon.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Adult from both sex
  • Neurosurgery requiring a functional diagnosis by cortical electrical stimulation OR a histological diagnosis with or without fluorescent agent (5-ALA) for a tumor pathology or epilepsy or an arteriovenous malformation.
  • Patient able to sign a non-opposition

排除标准

  • Impaired renal function defined by the presence of creatinine clearance less than 30ml/min
  • Patient under treatment with beta-blocker
  • Contraindication to performing an MRI (pacemaker)
  • Contraindication to the use of electrical cortical stimulation
  • History of life-threatening allergic reactions or known hypersensitivity to 5-ALA
  • Pregnant, breastfeeding woman
  • Subject participating in another interventional research including an exclusion period still ongoing at pre-inclusion,…
  • Persons deprived of liberty by a judicial or administrative decision
  • People receiving psychiatric care
  • Persons admitted to a health or social establishment for purposes other than research
  • Adults subject to a legal protection measure (guardianship, curatorship)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

结局指标

主要结局

Feasibility of recording video of useful quality to determine tissue quality

时间窗: Video will be recodered during surgery and feasibility will be assessed once all the video of all included patients will be recorded. 2-3 hours

The technical feasibility of the measurement will be determined by obtaining videos of sufficient quality to reach the detection threshold of the various functional and pathological markers. We will test the technical feasibility based on the expertise of the operator (researcher from the scientific team or operating room staff). This quality of the data will be judged using the expertise of CREATIS researchers. This quality is based on criteria linked to contrasts, signal-to-noise ratios, the absence of specular reflection artifacts and image movement. The evaluation methods which will be used during the meetings will be inspired by standard approaches from our previous work in collaboration with HCL

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 (2)

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