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

NCT03291977 | Completed Phase 3

• 1 other identifier: 35RC16_9758_FLEGME
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

surgery - glioblastoma - fluorescein

Outcome Measures

Primary Outcomes (1)

• Gross total removal rates

  assessed by the absence of residual contrast enhancement on early post-operative MRI

  under 72 hours post-op

Secondary Outcomes (4)

• Absolute volumes of tumor remnants

  under 72 hours post-op

• Relative volumes of tumor remnants

  under 72 hours post-op

• Occurrence of new neurological deficits

  under 72 hours post-op

• Occurrence of anaphylactic events related to the administration of fluorescein

  under 72 hours post-op

Study Arms (2)

Fluorescein sodique FAURE

EXPERIMENTAL

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

Drug: Fluorescéine Sodique Faure

White-light surgery

ACTIVE COMPARATOR

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

Procedure: White-light surgery

Interventions

Fluorescéine Sodique Faure 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.

Fluorescein sodique FAURE

White-light surgery PROCEDURE

The surgery will be performed under classical conditions

White-light surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Pierre-Jean LE RESTE, Dr

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: October 5, 2017
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)