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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291977
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 5, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291977


Contacts
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Contact: Pierre-Jean LE RESTE, Dr +33 2 99 28 42 77 pierre-jean.le.reste@chu-rennes.fr

Locations
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France
CHU Rennes Recruiting
Rennes, France
Contact: Pierre-Jean LE RESTE, Dr         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Pierre-Jean LE RESTE, Dr CHU Rennes
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03291977    
Other Study ID Numbers: 35RC16_9758_FLEGME
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
surgery - glioblastoma - fluorescein
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue