Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Videorecording.
- Who it may be relevant to
- Registry conditions: Brain Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Videorecording
Two cameras will be used to make the recordings: a classic camera placed on a stand 1 meter from your head, outside the sterile area and the color camera of the microscope used for the surgery.
Primary outcome measures
- Feasibility of recording video of useful quality to determine tissue quality [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hopital Pierre Wertheimer — Bron
Identifiers
NCT: NCT06651463 · 69HCL24_0709