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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioblastoma, Adult

Intervention / Treatment
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* Drug: Fluorescéine Sodique Faure
* Procedure: White-light surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery - glioblastoma - fluorescein