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Completed

NCT Number: NCT03291977

Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fluorescéine Sodique Faure

Drug

Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.

White-light surgery

Procedure

The surgery will be performed under classical conditions

Primary outcomes

  1. Gross total removal rates

    Time frame: under 72 hours post-op

    assessed by the absence of residual contrast enhancement on early post-operative MRI

Secondary outcomes

  1. Absolute volumes of tumor remnants

    Time frame: under 72 hours post-op

    assessed in cm3 on early post-operative MRI

  2. Relative volumes of tumor remnants

    Time frame: under 72 hours post-op

    assessed in % on early post-operative MRI

  3. Occurrence of new neurological deficits

    Time frame: under 72 hours post-op

    assessed by the NIHSS

  4. Occurrence of anaphylactic events related to the administration of fluorescein

    Time frame: under 72 hours post-op

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: FLEGME

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2017
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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