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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescein sodique FAURE | Experimental | Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia |
|
| White-light surgery | Active Comparator | In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescéine Sodique Faure | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Jean LE RESTE, Dr | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Rennes | France |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| White-light surgery | Procedure | The surgery will be performed under classical conditions |
|
| 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 |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |