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

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Glioblastoma, Adult

Treatments: Procedure: White-light surgery; Drug: Fluorescéine Sodique Faure

Study type: Interventional

Funder types: Other

Identifiers

NCT03291977

35RC16_9758_FLEGME

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Fluorescein sodique FAURE

Experimental group

Description:

Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia

Treatment:

Drug: Fluorescéine Sodique Faure

White-light surgery

Active Comparator group

Description:

In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).

Treatment:

Procedure: White-light surgery