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Clinical Trials in France / NCT06651463
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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

NCT06651463 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2025-12-18

Condition(s) studied

Brain Diseases

Investigational drug(s) / intervention(s)

Videorecording

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hopital Pierre Wertheimer Bron France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06651463 on ClinicalTrials.gov ↗ ← All trials in France