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

Sponsor

Rennes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03291977

Collaborator

(none)

Enrollment

Location

Arms

65.8

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma, Adult	Drug: Fluorescéine Sodique Faure Procedure: White-light surgery	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2017

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluorescein sodique FAURE Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia	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.
Active Comparator: White-light surgery In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).	Procedure: White-light surgery The surgery will be performed under classical conditions

Arm

Intervention/Treatment

Experimental: Fluorescein sodique FAURE

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

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.

Active Comparator: White-light surgery

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

Procedure: White-light surgery

The surgery will be performed under classical conditions

Outcome Measures

Primary Outcome Measures

Gross total removal rates [under 72 hours post-op]
assessed by the absence of residual contrast enhancement on early post-operative MRI

Secondary Outcome Measures

Absolute volumes of tumor remnants [under 72 hours post-op]
assessed in cm3 on early post-operative MRI
Relative volumes of tumor remnants [under 72 hours post-op]
assessed in % on early post-operative MRI
Occurrence of new neurological deficits [under 72 hours post-op]
assessed by the NIHSS
Occurrence of anaphylactic events related to the administration of fluorescein [under 72 hours post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Rennes	Rennes		France

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator: Pierre-Jean LE RESTE, Dr, CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT03291977

Other Study ID Numbers:

35RC16_9758_FLEGME

First Posted:

Sep 25, 2017

Last Update Posted:

Jan 6, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rennes University Hospital

surgery - glioblastoma - fluorescein

Additional relevant MeSH terms:

Glioblastoma

Study Results

No Results Posted as of Jan 6, 2021