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NCT Number: NCT06651463

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

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.

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videorecording

Other

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 outcomes

  1. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Julien Berthiller

CONTACT

[email protected]

04 27 85 63 01

Thiébaud PICART

CONTACT

[email protected]

04 72 35 75 70

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: NEUROVISION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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