Glioblastoma, Adult
Conditions
Keywords
surgery - glioblastoma - fluorescein
Brief 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.
Interventions
DRUGFluorescéine 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.
PROCEDUREWhite-light surgery
The surgery will be performed under classical conditions
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross total removal rates | under 72 hours post-op | assessed by the absence of residual contrast enhancement on early post-operative MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative volumes of tumor remnants | under 72 hours post-op | assessed in % on early post-operative MRI |
| Occurrence of new neurological deficits | under 72 hours post-op | assessed by the NIHSS |
| Absolute volumes of tumor remnants | under 72 hours post-op | assessed in cm3 on early post-operative MRI |
| Occurrence of anaphylactic events related to the administration of fluorescein | under 72 hours post-op | — |
Countries
France
Outcome results
None listed