Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO)

Acerbi, Francesco and Broggi, Morgan and Schebesch, Karl-Michael and Hoehne, Julius and Cavallo, Claudio and De Laurentis, Camilla and Eoli, Marica and Anghileri, Elena and Servida, Maura and Boffano, Carlo and Pollo, Bianca and Schiariti, Marco and Visintini, Sergio and Montomoli, Cristina and Bosio, Lorenzo and La Corte, Emanuele and Broggi, Giovanni and Brawanski, Alexander and Ferroli, Paolo (2018) Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO). CLINICAL CANCER RESEARCH, 24 (1). pp. 52-61. ISSN 1078-0432, 1557-3265

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Abstract

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 article, 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 HGGs considered suitable for removal were eligible to participate in this trial. Fluorescein was intravenously injected at a dose of 5 to 10 mg/kg. The primary endpoint was the percentage of patients with histologically confirmed HGGs, without contrast-enhancing tumor at the immediate postoperative MRI. Secondary endpoints were PFS, residual tumor on postoperative MRI, overall survival, neurologic deficits, and fluorescein-related toxicity. The sensitivity and specificity of fluorescein in identifying tumor tissue were estimated by fluorescent and nonfluorescent 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 to 75 years were screened for participation, and 46 were considered for primary and secondary endpoints. Mean preoperative tumor volume was 28.75 cm(3) (range, 1.3-87.8 cwebsite). 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 specificity of fluorescein in identifying tumor tissue were respectively 80.8% and 79.1%. Conclusions: 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 HGGs. (C) 2017 AACR.

Item Type: Article
Uncontrolled Keywords: GLIOBLASTOMA-MULTIFORME; MALIGNANT GLIOMA; ADJUVANT TEMOZOLOMIDE; SAFE-RESECTION; RESIDUAL TUMOR; SURVIVAL; EXTENT; SODIUM; BRAIN; MICROSCOPE;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Neurochirurgie
Medicine > Abteilung für Neuropathologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 23 Mar 2020 13:04
Last Modified: 23 Mar 2020 13:04
URI: https://pred.uni-regensburg.de/id/eprint/15367

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