Clinical trial NCT06651463: Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
Official title: Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Diseases
Keywords: feasibility
tissue identification
neurosurgery
video
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of recording video of useful quality to determine tissue quality
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Pierre Wertheimer
Study officials:
References: