cropped color_logo_with_background.png

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 79 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03291977
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rennes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pierre-Jean LE RESTE, Dr
Principal Investigator Affiliation CHU Rennes
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Adult
Arms & Interventions

Arms

Experimental: Fluorescein sodique FAURE

Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia

Active Comparator: White-light surgery

In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).

Interventions

Drug: - Fluorescéine Sodique Faure

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.

Procedure: - White-light surgery

The surgery will be performed under classical conditions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Rennes, Rennes, France

Status

Address

CHU Rennes

Rennes, ,