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

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma, Adult
• Intervention / Treatment: Drug: Fluorescéine Sodique Faure; Procedure: White-light surgery

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescein sodique FAURE; Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia	Drug: 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.
Active Comparator: White-light surgery; In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).	Procedure: White-light surgery; The surgery will be performed under classical conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross total removal rates	assessed by the absence of residual contrast enhancement on early post-operative MRI	under 72 hours post-op

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Pierre-Jean LE RESTE, Dr, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: surgery - glioblastoma - fluorescein
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 35RC16_9758_FLEGME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No