CHU Rennes
Rennes, France
NCT Number: NCT03291977
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.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 3
Rennes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: under 72 hours post-op
assessed by the absence of residual contrast enhancement on early post-operative MRI
Time frame: under 72 hours post-op
assessed in cm3 on early post-operative MRI
Time frame: under 72 hours post-op
assessed in % on early post-operative MRI
Time frame: under 72 hours post-op
assessed by the NIHSS
Time frame: under 72 hours post-op
Rennes University Hospital
Other
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
Acronym: FLEGME
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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