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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06651463
Acronym
NEUROVISION
Enrollment
50
Registered
2024-10-21
Start date
2026-01-01
Completion date
2028-01-01
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases

Keywords

feasibility, tissue identification, neurosurgery, video

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.

Interventions

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of recording video of useful quality to determine tissue qualityVideo will be recodered during surgery and feasibility will be assessed once all the video of all included patients will be recorded. 2-3 hoursThe 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

Countries

France

Contacts

Primary ContactThiébaud PICART
thiebaud.picart@chu-lyon.fr04 72 35 75 70
Backup ContactJulien Berthiller
Julien.berthiller@chu-lyon.fr04 27 85 63 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026