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

NCT ID: NCT03291977

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2022-01-18

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.

Conditions

Glioblastoma, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluorescein sodique FAURE

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

Group Type: EXPERIMENTAL

Fluorescéine Sodique Faure

Intervention Type: DRUG

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.

White-light surgery

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

Group Type: ACTIVE_COMPARATOR

White-light surgery

Intervention Type: PROCEDURE

The surgery will be performed under classical conditions

Interventions

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.

Intervention Type: DRUG

White-light surgery

The surgery will be performed under classical conditions

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Jean LE RESTE, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC16_9758_FLEGME

Identifier Type: -

Identifier Source: org_study_id