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

Phase 3

Completed

• Conditions: Glioblastoma, Adult
• Interventions: Procedure: White-light surgery; Drug: Fluorescéine Sodique Faure

• Registration Number: NCT03291977
• Lead Sponsor: Rennes University Hospital

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

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-25
• Study Start: 2017-10-05
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White-light surgery	White-light surgery	In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
Fluorescein sodique FAURE	Fluorescéine Sodique Faure	Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia

Primary Outcome Measures

Name	Time	Method
Gross total removal rates	under 72 hours post-op	assessed by the absence of residual contrast enhancement on early post-operative MRI

Secondary Outcome Measures

Name	Time	Method
Occurrence of new neurological deficits	under 72 hours post-op	assessed by the NIHSS
Absolute volumes of tumor remnants	under 72 hours post-op	assessed in cm3 on early post-operative MRI
Occurrence of anaphylactic events related to the administration of fluorescein	under 72 hours post-op
Relative volumes of tumor remnants	under 72 hours post-op	assessed in % on early post-operative MRI

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France