drugset / Trial / NCT03291977

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

NCT03291977

Phase 3 Completed 51 enrolled Rennes University Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-10-05
Primary completion
2022-01-18
Completion
2022-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluorescein Diagnostic / imaging agent 3 mg/kg Intravenous

Indications