Confocal Laser Endomicroscopy for Brain Tumors

Phase 1

Terminated

• Conditions: Low Grade Glioma (LGG), High Grade Glioma (HGG)
• Interventions: Procedure: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)

• Registration Number: NCT02240758
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgical removal of the tumors+stereotaxic biopsy	confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	Safety will be assessed by the number, type and severity of recorded adverse events.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France