Departments of Neurosurgery.
Neurosurg Focus. 2014 Feb;36(2):E5. doi: 10.3171/2013.11.FOCUS13487.
Fluorescein, a dye that is widely used as a fluorescent tracer, accumulates in cerebral areas where the blood-brain barrier is damaged. This quality makes it an ideal dye for the intraoperative visualization of high-grade gliomas (HGGs). The authors report their experience with a new fluorescein-guided technique for the resection of HGGs using a dedicated filter on the surgical microscope.
The authors initiated a prospective Phase II trial (FLUOGLIO) in September 2011 with the objective of evaluating the safety of fluorescein-guided surgery for HGGs and obtaining preliminary evidence regarding its efficacy for this purpose. To be eligible for participation in the study, a patient had to have suspected HGG amenable to complete resection of the contrast-enhancing area. The present report is based on the analysis of the short- and long-term results in 20 consecutive patients with HGGs (age range 45-74 years), enrolled in the study since September 2011. In all cases fluorescein (5-10 mg/kg) was injected intravenously after intubation. Tumor resection was performed with microsurgical technique and fluorescence visualization by means of BLUE 400 or YELLOW 560 filters on a Pentero microscope.
The median preoperative tumor volume was 30.3 cm(3) (range 2.4-87.8 cm(3)). There were no adverse reactions related to fluorescein administration. Complete removal of contrast-enhanced tumor was achieved in 80% of the patients. The median duration of follow-up was 10 months. The 6-months progression-free survival rate was 71.4% and the median survival was 11 months.
Analysis of these 20 cases suggested that fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and allows a high rate of complete resection of contrast-enhanced tumor as determined on early postoperative MRI. Clinical trial registration no.: 2011-002527-18 (EudraCT).
荧光素作为一种广泛用作荧光示踪剂的染料,会在血脑屏障受损的脑区积聚。这种特性使其成为高级别胶质瘤(HGG)术中可视化的理想染料。作者报告了一种使用手术显微镜上专用滤光片引导切除 HGG 的新型荧光素引导技术的经验。
作者于 2011 年 9 月启动了一项前瞻性 II 期试验(FLUOGLIO),目的是评估荧光素引导手术治疗 HGG 的安全性,并获得该方法对此类疾病的初步疗效证据。为了有资格参加该研究,患者必须患有疑似 HGG,且增强区域可完全切除。本报告基于对 2011 年 9 月以来纳入研究的 20 例连续 HGG 患者(年龄 45-74 岁)的短期和长期结果进行的分析。在所有情况下,荧光素(5-10mg/kg)在插管后静脉注射。使用显微镜技术和 Pentero 显微镜上的 BLUE 400 或 YELLOW 560 滤光片进行肿瘤切除。
术前肿瘤体积中位数为 30.3cm³(范围 2.4-87.8cm³)。无与荧光素给药相关的不良反应。80%的患者实现了增强肿瘤的完全切除。中位随访时间为 10 个月。6 个月无进展生存率为 71.4%,中位生存期为 11 个月。
对这 20 例患者的分析表明,手术显微镜上专用滤光片引导的荧光素技术安全,可实现高比例的增强肿瘤完全切除,这是通过术后早期 MRI 确定的。临床试验注册号:2011-002527-18(EudraCT)。