Brain DiseasesNEUROVISIONNCT06651463
Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
A study testing Videorecording in people with Brain Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Diseases
- What is being tested?
- Videorecording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Pierre Wertheimer
Bron, 69500
Thiébaud PICART, 04 72 35 75 70, thiebaud.picart@chu-lyon.fr
About this study
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.
- Conditions
- Brain Diseases
- Being tested
- Videorecording
- Keywords
- feasibility, tissue identification, neurosurgery, video
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideorecordingOther
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 group | Role | What they receive |
|---|---|---|
| Video Capture | Experimental | 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. Receives: Other: Videorecording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recording video of useful quality to determine tissue quality
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651463
- Sponsor's protocol ID
- 69HCL24_0709
- Acronym
- NEUROVISION
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence
- ClinicalTrials.gov ID
- NCT06651463
- Acronym / sponsor ID
- NEUROVISION / 69HCL24_0709
- Conditions
- Brain Diseases
- Keywords
- feasibility, tissue identification, neurosurgery, video
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Capture | Experimental | Other: VideorecordingBrain 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideorecordingTwo 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. | Other | Video Capture |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videorecording in people with Brain Diseases, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thiébaud PICART (04 72 35 75 70, thiebaud.picart@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.