Article
Preliminary results of a multicentre phase-II study (FLUOGLIO) on fluorescein-guided surgery for resection of malignant gliomas
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Published: | June 2, 2015 |
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Objective: Sodium fluorescein capability to accumulate in cerebral areas with blood-brain barrier damage makes it an ideal dye for intraoperative visualization of high-grade gliomas (HGG). A fluorescein-guided technique for HGG removal with a dedicated filter on the surgical microscope is presented (FLUOGLIO trial).
Method: The FLUOGLIO study is a prospective multicentre phase II-trial to evaluate safety and obtain indications about efficacy of fluorescein-guided surgery for HGG. Until November 2014, 36 patients (mean age 62.6, range 40-75) were enrolled. Fluorescein was intravenously injected after intubation or immediately before the procedure in awake patients (5-10 mg/Kg). Tumor was removed with microsurgical technique and fluorescence visualization by BLU400 or YELLOW560 filters on the Pentero microscope (Carl Zeiss, Germany). Degree of tumor resection was calculated on an early (within 72 hours of surgery) postoperative MRI.
In 12 patients, biopsies were performed at the tumor margin to evaluate sensitivity and specificity of fluorescein in tumor tissue identification.
Results: Median pre-operative tumor volume was 29.7 cm3 (1.3-87.8 cm3). No adverse reaction related to the administration of fluorescein was registered. Contrast-enhanced tumor was completely removed in 86% of the patients on early postoperative MRI (31/36). The remaining patients had a mean tumor resection of 92%. With a median follow-up of 14 months, the 6 months PFS rate was 78% and median survival was 14 months. Estimation of sensitivity and specificity of fluorescein in identifying tumor tissue was 83% and 82% respectively.
Conclusions: Fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and allows a high-rate of complete resection of HGG at the early post-operative MRI.