跳至主要内容
临床试验/NCT03291977
NCT03291977已完成3 期

Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年10月5日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Interest of Fluorescein in Fluorescence-guided... | 临床试验