Clinical trial · Interventional
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma, Adult | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescéine Sodique Faure | Drug | — | UNRESOLVED |
| White-light surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluorescein sodique FAURE
- description
- Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia
- interventionNames
- Drug: Fluorescéine Sodique Faure
- type
- ACTIVE_COMPARATOR
- label
- White-light surgery
- description
- In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
- interventionNames
- Procedure: White-light surgery
Primary outcomes (1)
- measure
- Gross total removal rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available