Low Grade Glioma (LGG), High Grade Glioma (HGG) Clinical Trial
— GLIOFOCALOfficial title:
INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | January 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | Yes |