Fluorescein-guided surgery for resection of high-grade gliomas: A multicentric prospective phase II study (FLUOGLIO).

Purpose Sodium Fluorescein is a dye that, intravenously injected, selectively accumulates in high-grade glioma (HGG) tissue through a damaged blood-brain barrier. In this paper, the final results of a multicentric prospective phase II trial (FLUOGLIO) on fluorescein-guided HGG resection through a dedicated filter on the surgical microscope were reported. Methods Patients with suspected HGG considered suitable for removal were eligible to participate in this trial. Fluorescein was intravenously injected at a dose of 5-10 mg/Kg. Primary endpoint was the percentage of patients with histologically-confirmed HGG, without contrast-enhancing tumor at the immediate post-operative MRI. Secondary endpoints were progression free survival (PFS), residual tumor on postoperative MRI, overall survival, neurological deficits and fluorescein-related toxicity. The sensitivity and specificity of fluorescein in identifying tumor tissue were estimated by fluorescent and non-fluorescent biopsies at the tumor margin. The study was registered on the European Regulatory Authorities website (EudraCT 2011-002527-18). Results Fifty-seven patients aged 45-75 years were screened for participation and 46 were considered for primary and secondary endpoints. Mean pre-operative tumor volume was 28.75 cm3 (range 1.3-87.8 cm3). Thirty-eight patients (82.6%) underwent a complete tumor removal. Median follow-up was 11 months. PFS-6 and PFS-12 were 56,6% and 15.2%. Median survival was 12 months. No adverse reaction related to SF administration was recorded. The sensitivity and specifity of fluorescein in identifying tumor tissue were respectively 80.8% and 79.1%. Conclusion Fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and enables a high percentage of contrast-enhancing tumor in patients with HGG.

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