Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Gross total removal rates
研究概览
简要总结
Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 79
- •Karnofsky index > 70 %
- •Brain MRI showing a parenchymal lesion with typical features of glioblastoma, < 1week
- •Achievable gross total removal, as assessed by the neurosurgical staff
- •Written consent
排除标准
- •Contraindication to fluorescein
- •Contraindication to MRI
- •History of brain surgery <6 months
- •Guardianship, tutelage or deprivation of liberty
- •Pregnancy or breastfeeding
- •Participation to other interventional clinical studies
研究组 & 干预措施
Fluorescein sodique FAURE
Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia
干预措施: Fluorescéine Sodique Faure (Drug)
White-light surgery
In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
干预措施: White-light surgery (Procedure)
结局指标
主要结局
Gross total removal rates
时间窗: under 72 hours post-op
assessed by the absence of residual contrast enhancement on early post-operative MRI
次要结局
- Occurrence of new neurological deficits(under 72 hours post-op)
- Absolute volumes of tumor remnants(under 72 hours post-op)
- Occurrence of anaphylactic events related to the administration of fluorescein(under 72 hours post-op)
- Relative volumes of tumor remnants(under 72 hours post-op)
