Artikel
Fluorescein Sodium and YELLOW 560nm filter for improved resection of primary high-grade gliomas – the FLUOGLIO trial
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Veröffentlicht: | 8. Juni 2016 |
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Objective: Fluorescein is used as a fluorescent tracer for several applications. Its capability to accumulate in cerebral areas where the blood-brain barrier has been damaged can be exploited for the intraoperative visualization of high-grade gliomas (HGG). The results of a prospective multicentric (Besta Institute in Milan and University Hospital in Regensburg) phase II trial on fluorescein-guided technique resection of HGG (FLUOGLIO) are presented.
Method: In September 2011 the FLUOGLIO study was started to evaluate safety and efficacy of fluorescein-guided surgery for HGG. 46 patients (mean age 63, range 40-74) have been enrolled. Fluorescein was injected after intubation or immediately at the entrance in the OR for awake patients (5-10 mg/kg). Intraoperative visualization was performed with a dedicated filter on the surgical microscope (BLU400 or YELLOW560, Pentero Zeiss). In 13 patients, up to 4 biopsies were performed at the tumor margin in fluorescent and non-fluorescent areas to evaluate sensitivity and specificity of fluorescein in tumor tissue identification. Patients were submitted to post-operative Stupp protocol and followed-up to evaluate progression free survival (PFS) and overall survival (OS).
Results: Mean pre-operative tumor volume was 28.74 cm3. Complete resection was achieved in 83% of patients on early postoperative MRI. No adverse reactions related to fluorescein administration were registered. An immediate slight deterioration in NIHSS (1.2 ± 0.2 vs 2.9 ± 0.6) and KPS (87.4 ± 1.7 vs 78.2 ± 2.6) was registered. With a mean follow-up of 13 months, the 6 months PFS rate was 73.3% Sensitivity and specificity of fluorescein in identifying tumor tissue was 80.8% and 79.1% respectively.
Conclusions: The results of FLUOGLIO study suggest that fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and allows a high-rate of complete resection of HGG as confirmed at the early post-operative MRI.