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

Francesco Acerbi, Morgan Broggi, Karl Michael Schebesch, Julius Höhne, Claudio Cavallo, Camilla De Laurentis, Marica Eoli, Elena Anghileri, Maura Servida, Carlo Boffano, Bianca Pollo, Marco Schiariti, Sergio Visintini, Cristina Montomoli, Lorenzo Bosio, Emanuele La Corte, Giovanni Broggi, Alexander Brawanski, Paolo Ferroli

Research output: Contribution to journalArticle

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 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.

Original languageEnglish
Pages (from-to)52-61
Number of pages10
JournalClinical Cancer Research
Volume24
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

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Fluorescein
Glioma
Neoplasms
Sensitivity and Specificity
Survival
Residual Neoplasm
Neurologic Manifestations
Tumor Burden
Blood-Brain Barrier
Coloring Agents
Biopsy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Fluorescein-guided surgery for resection of high-grade gliomas : A multicentric prospective phase II study (FLUOGLIO). / Acerbi, Francesco; Broggi, Morgan; Schebesch, Karl Michael; Höhne, Julius; Cavallo, Claudio; De Laurentis, Camilla; Eoli, Marica; Anghileri, Elena; Servida, Maura; Boffano, Carlo; Pollo, Bianca; Schiariti, Marco; Visintini, Sergio; Montomoli, Cristina; Bosio, Lorenzo; Corte, Emanuele La; Broggi, Giovanni; Brawanski, Alexander; Ferroli, Paolo.

In: Clinical Cancer Research, Vol. 24, No. 1, 01.01.2018, p. 52-61.

Research output: Contribution to journalArticle

Acerbi, Francesco ; Broggi, Morgan ; Schebesch, Karl Michael ; Höhne, Julius ; Cavallo, Claudio ; De Laurentis, Camilla ; Eoli, Marica ; Anghileri, Elena ; Servida, Maura ; Boffano, Carlo ; Pollo, Bianca ; Schiariti, Marco ; Visintini, Sergio ; Montomoli, Cristina ; Bosio, Lorenzo ; Corte, Emanuele La ; Broggi, Giovanni ; Brawanski, Alexander ; Ferroli, Paolo. / Fluorescein-guided surgery for resection of high-grade gliomas : A multicentric prospective phase II study (FLUOGLIO). In: Clinical Cancer Research. 2018 ; Vol. 24, No. 1. pp. 52-61.
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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 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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T1 - Fluorescein-guided surgery for resection of high-grade gliomas

T2 - A multicentric prospective phase II study (FLUOGLIO)

AU - Acerbi, Francesco

AU - Broggi, Morgan

AU - Schebesch, Karl Michael

AU - Höhne, Julius

AU - Cavallo, Claudio

AU - De Laurentis, Camilla

AU - Eoli, Marica

AU - Anghileri, Elena

AU - Servida, Maura

AU - Boffano, Carlo

AU - Pollo, Bianca

AU - Schiariti, Marco

AU - Visintini, Sergio

AU - Montomoli, Cristina

AU - Bosio, Lorenzo

AU - Corte, Emanuele La

AU - Broggi, Giovanni

AU - Brawanski, Alexander

AU - Ferroli, Paolo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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 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.

AB - 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 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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