Glioblastoma, AdultPhase 3FLEGMENCT03291977
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)
A Phase 3 study testing Fluorescéine Sodique Faure and White-light surgery in people with Glioblastoma, Adult, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Glioblastoma, Adult
- What is being tested?
- Fluorescéine Sodique Faure and White-light surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2017to 18 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
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.
- Conditions
- Glioblastoma, Adult
- Being tested
- Fluorescéine Sodique Faure, White-light surgery
- Keywords
- surgery - glioblastoma - fluorescein
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescéine Sodique FaureDrug
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 surgeryProcedure or surgery
The surgery will be performed under classical conditions
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein sodique FAURE | Experimental | Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia Receives: Drug: Fluorescéine Sodique Faure |
| White-light surgery | Active comparator | In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery). Receives: Procedure: White-light surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross total removal rates
assessed by the absence of residual contrast enhancement on early post-operative MRI
Measured: under 72 hours post-op
Secondary outcomes (4)
Absolute volumes of tumor remnants
assessed in cm3 on early post-operative MRI
Measured: under 72 hours post-op
Relative volumes of tumor remnants
assessed in % on early post-operative MRI
Measured: under 72 hours post-op
Occurrence of new neurological deficits
assessed by the NIHSS
Measured: under 72 hours post-op
Occurrence of anaphylactic events related to the administration of fluorescein
Measured: under 72 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start5 Oct 2017
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, AdultStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Jean LE RESTE, Dr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291977
- Sponsor's protocol ID
- 35RC16_9758_FLEGME
- Acronym
- FLEGME
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2017
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
- ClinicalTrials.gov ID
- NCT03291977
- Acronym / sponsor ID
- FLEGME / 35RC16_9758_FLEGME
- Conditions
- Glioblastoma, Adult
- Keywords
- surgery - glioblastoma - fluorescein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescein sodique FAURE | Experimental | Drug: Fluorescéine Sodique FaureFluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia |
| White-light surgery | Active comparator | Procedure: White-light surgeryIn the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication to fluorescein
- Contraindication to MRI
- History of brain surgery <6 months
- Guardianship, tutelage or deprivation of liberty
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescéine Sodique FaureFluorescéine 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. | Drug | Fluorescein sodique FAURE |
| White-light surgeryThe surgery will be performed under classical conditions | Procedure or surgery | White-light surgery |
Primary outcome
Gross total removal rates
Time frame: under 72 hours post-op
assessed by the absence of residual contrast enhancement on early post-operative MRI
4 secondary outcomes
Absolute volumes of tumor remnants
Time frame: under 72 hours post-op
Relative volumes of tumor remnants
Time frame: under 72 hours post-op
Occurrence of new neurological deficits
Time frame: under 72 hours post-op
Occurrence of anaphylactic events related to the administration of fluorescein
Time frame: under 72 hours post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Jean LE RESTE, Dr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorescéine Sodique Faure and White-light surgery in people with Glioblastoma, Adult, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross total removal rates (time frame: under 72 hours post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.