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

Glioblastoma, Adult Clinical Trial

— FLEGME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291977
• Other study ID #: 35RC16_9758_FLEGME
• Status: Completed
• Phase: Phase 3
• Start date: October 5, 2017
• Est. completion date: January 18, 2022

Study information

• Verified date: November 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma, Adult

Intervention

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.

Procedure:
• White-light surgery
The surgery will be performed under classical conditions

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross total removal rates	assessed by the absence of residual contrast enhancement on early post-operative MRI	under 72 hours post-op
Secondary	Absolute volumes of tumor remnants	assessed in cm3 on early post-operative MRI	under 72 hours post-op
Secondary	Relative volumes of tumor remnants	assessed in % on early post-operative MRI	under 72 hours post-op
Secondary	Occurrence of new neurological deficits	assessed by the NIHSS	under 72 hours post-op
Secondary	Occurrence of anaphylactic events related to the administration of fluorescein		under 72 hours post-op