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

Primary Purpose

Glioblastoma, Adult

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Fluorescéine Sodique Faure
White-light surgery
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma, Adult focused on measuring surgery - glioblastoma - fluorescein

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluorescein sodique FAURE

White-light surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gross total removal rates
assessed by the absence of residual contrast enhancement on early post-operative MRI

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2017
Last Updated
November 8, 2022
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03291977
Brief Title
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)
Acronym
FLEGME
Official Title
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Adult
Keywords
surgery - glioblastoma - fluorescein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluorescein sodique FAURE
Arm Type
Experimental
Arm Description
Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia
Arm Title
White-light surgery
Arm Type
Active Comparator
Arm Description
In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
Intervention Type
Drug
Intervention Name(s)
Fluorescéine Sodique Faure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
White-light surgery
Intervention Description
The surgery will be performed under classical conditions
Primary Outcome Measure Information:
Title
Gross total removal rates
Description
assessed by the absence of residual contrast enhancement on early post-operative MRI
Time Frame
under 72 hours post-op
Secondary Outcome Measure Information:
Title
Absolute volumes of tumor remnants
Description
assessed in cm3 on early post-operative MRI
Time Frame
under 72 hours post-op
Title
Relative volumes of tumor remnants
Description
assessed in % on early post-operative MRI
Time Frame
under 72 hours post-op
Title
Occurrence of new neurological deficits
Description
assessed by the NIHSS
Time Frame
under 72 hours post-op
Title
Occurrence of anaphylactic events related to the administration of fluorescein
Time Frame
under 72 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Jean LE RESTE, Dr
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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