Confocal Laser Endomicroscopy for Brain Tumors (GLIOFOCAL)

Civil Hospices of Lyon

Status and phase

Terminated

Phase 1

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02240758

2013-820

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.