Clinical trial · Interventional
Confocal Laser Endomicroscopy for Brain Tumors
INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Grade Glioma (LGG), High Grade Glioma (HGG) | Glioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- surgical removal of the tumors+stereotaxic biopsy
- interventionNames
- Procedure: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)
Primary outcomes (1)
- measure
- To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
- timeFrame
- End of the surgical procedure
- description
- 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 outcomes (1)
- measure
- To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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