Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
NCT ID: NCT06651463
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-01
2028-01-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Video Capture
Brain of patients, presenting a brain pathology eligible for a neurosurgery operation requiring a standard functional and/or histological diagnosis at HCL, will be video recorded with colorimetric cameras in order to evaluate the feasibility of identifying tissue.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hopital Pierre Wertheimer
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Thiébaud PICART
Role: primary
Other Identifiers
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69HCL24_0709
Identifier Type: -
Identifier Source: org_study_id