Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence (NEUROVISION)
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julien BERTHILLER
- Phone Number: 04 27 85 63 01
- Email: julien.berthiller@chu-lyon.fr
Study Contact Backup
- Name: Thiébaud PICART
- Phone Number: 04 72 35 75 70
- Email: thiebaud.picart@chu-lyon.fr
Study Locations
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Bron, France, 69500
- Hopital Pierre Wertheimer
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Contact:
- Thiébaud PICART
- Phone Number: 04 72 35 75 70
- Email: thiebaud.picart@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_0709
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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