Confocal Laser Endomicroscopy for Brain Tumors

Study Overview
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Brief Summary
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Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.

Official Title
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INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN

Conditions
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Low Grade Glioma (LGG), High Grade Glioma (HGG)

Intervention / Treatment
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* Procedure: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old Clinical signs and history of the disease in favor of a HGG, LGG MRI study in favor of a HGG, LGG, meningioma or brain metastasis Affiliated to or beneficiary of a social security system (or equivalent). Patients who have provided written informed consent for the study Exclusion Criteria: - Allergy to fluorescein Previous life-threatening allergic reactions and known hypersensitivity Pregnant or lactating or not using effective contraception; Restricted renal function define by a creatinine clearance < 30ml/min Patients under a beta-blockers treatment Contraindication to do an MRI (pace-maker) Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria Minor or adult ward of court (under guardianship or trusteeship) No affiliation to a social security system (or equivalent). Patients who express opposition to participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgical removal of the tumors+stereotaxic biopsy<br> | Procedure: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)<br>* The CELLVIZIO® system (Mauna Kea technology) will be used for confocal endomicroscopy during a surgical procedure (either open surgical approach or stereotaxic biopsy). The probe dedicated to the CELLVIZIO® system will be positioned against the surface of the brain, sequences will be acquired, and finally compared with anatomapathology exams. Two specific medications will be used as contrast agent in the study: Fluorescein FAURE 500mg/5mL IV with a maximum of two doses per patient OR 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies. | The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies. | End of the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies. | Safety will be assessed by the number, type and severity of recorded adverse events. | 14 days after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, confocal laser endomicroscopy