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Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO)
Author(s): ,
F. Acerbi
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
M. Broggi
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
K.M. Schebesch
Affiliations:
University Hospital Regensburg, Regensburg, Germany
,
J. Höhne
Affiliations:
University Hospital Regensburg, Regensburg, Germany
,
C. Cavallo
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
C. Delaurentis
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
M. Eoli
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurology, Milano, Italy
,
E. Anghileri
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurology, Milano, Italy
,
B. Pollo
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neuropathology, Milano, Italy
,
M. Servida
Affiliations:
Ospedale di Legnano, Legnano, Italy
,
C. Boffano
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neuroradiology, Milano, Italy
,
C. Montomoli
Affiliations:
University of Pavia, Pavia, Italy
,
J. Falco
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
M. Schiariti
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
G. Broggi
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
,
A. Brawanski
Affiliations:
University Hospital Regensburg, Regensburg, Germany
P. Ferroli
Affiliations:
Foundation IRCCS Istituto Neurologico Carlo Besta, Neurosurgery, Milano, Italy
EANS Academy. Acerbi F. Oct 21, 2018; 225922; EP3091
Dr. Francesco Acerbi
Dr. Francesco Acerbi
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Abstract
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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 study, 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 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 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.
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