Confocal Laser Endomicroscopy for Brain Tumors
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 10/31/2015 |
| Pirmasis pateikimas: | 09/11/2014 |
| Numatytas registravimas pateiktas: | 09/14/2014 |
| Pirmas paskelbtas: | 09/15/2014 |
| Paskutinis atnaujinimas pateiktas: | 11/24/2015 |
| Paskutinis atnaujinimas paskelbtas: | 11/25/2015 |
| Faktinė studijų pradžios data: | 08/31/2014 |
| Numatoma pirminio užbaigimo data: | 09/30/2014 |
| Numatoma studijų užbaigimo data: | 12/31/2014 |
Būklė ar liga
Intervencija / gydymas
Procedure: surgical removal of the tumors+stereotaxic biopsy
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: surgical removal of the tumors+stereotaxic biopsy | Procedure: surgical removal of the tumors+stereotaxic biopsy 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies. [End of the surgical procedure]
Antrinės rezultatų priemonės
1. To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies. [14 days after inclusion]
