NCT03291977

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma, Adult

Interventions

Type	Name	Description
DRUG	Fluorescéine Sodique Faure	Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.
PROCEDURE	White-light surgery	The surgery will be performed under classical conditions

Timeline

• Start date: 2017-10-05
• Primary completion: 2022-01-18
• Completion: 2022-01-18
• First posted: 2017-09-25
• Last updated: 2022-11-09

Locations

1 site across 1 country: France