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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital

Criteria

Inclusion Criteria:

• Age between 18 and 79

• Karnofsky index > 70 %

• Brain MRI showing a parenchymal lesion with typical features of glioblastoma, < 1week

• Achievable gross total removal, as assessed by the neurosurgical staff

• Written consent

Exclusion Criteria:

• Contraindication to fluorescein

• Contraindication to MRI

• History of brain surgery <6 months

• Guardianship, tutelage or deprivation of liberty

• Pregnancy or breastfeeding

• Participation to other interventional clinical studies