A Phase 3 interventional study of Fluorescéine Sodique Faure and White-light surgery in Glioblastoma, Adult, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Rennes University Hospital · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia
Drug: Fluorescéine Sodique Faure
In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
Procedure: White-light surgery
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.
The surgery will be performed under classical conditions
Gross total removal rates
assessed by the absence of residual contrast enhancement on early post-operative MRI
Time frame: under 72 hours post-op
Absolute volumes of tumor remnants
assessed in cm3 on early post-operative MRI
Time frame: under 72 hours post-op
Relative volumes of tumor remnants
assessed in % on early post-operative MRI
Time frame: under 72 hours post-op
Occurrence of new neurological deficits
assessed by the NIHSS
Time frame: under 72 hours post-op
Occurrence of anaphylactic events related to the administration of fluorescein
Time frame: under 72 hours post-op
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital