Confocal Laser Endomicroscopy for Brain Tumors

Phase 1TerminatedNCT02240758

Hospices Civils de Lyon10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: End of the surgical procedure

Secondary Outcomes

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.

Time frame: 14 days after inclusion

Data from ClinicalTrials.gov

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