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Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME) — FLEGME  

Glioblastoma, Adult Clinical Trial

Official title:
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study

Clinical Trial Summary

Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03291977
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase Phase 3
Start date October 5, 2017
Completion date January 18, 2022
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