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Spots Global Cancer Trial Database for Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)

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Trial Identification

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

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

Study ID: NCT03291977

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Rennes, Rennes, , France

Contact Details

Name: Pierre-Jean LE RESTE, Dr

Affiliation: CHU Rennes

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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