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

Launched by HOSPICES CIVILS DE LYON · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help neurosurgeons identify healthy and unhealthy areas of the brain during surgery. The study aims to see if using a special camera can measure the color and texture of brain tissue more accurately than the human eye can. This could help surgeons make better decisions during operations, potentially leading to improved outcomes for patients with brain diseases.

To participate in this trial, you need to be an adult who is scheduled for neurosurgery that requires either a functional diagnosis (checking how the brain is working) or a histological diagnosis (looking at tissue under a microscope). Some common conditions that might qualify include tumors, epilepsy, or abnormal blood vessels in the brain. However, there are some exclusions, such as having certain health issues or being pregnant. If you join, you can expect to undergo standard neurosurgery procedures, and researchers will also use the camera technology to gather information during your surgery. This trial is currently not recruiting participants, but it hopes to improve surgical techniques in the future.

Gender

ALL

Eligibility criteria

• 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