Fluorescence Spectroscopy Guided Surgery (GLIOSPECT)

Civil Hospices of Lyon

Status and phase

Completed

Phase 1

Conditions

Low Grade Glioma (LGG)

High Grade Glioma (HGG)

Treatments

Device: Fluorescence spectroscopy guided surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02473380

69HCL14-0270

Details and patient eligibility

About

Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future 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. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.

Enrollment

11 patients

Sex

All

Ages

19+ 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

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.