Low Grade Glioma (LGG)Phase 1GLIOSPECTNCT02473380
Fluorescence Spectroscopy Guided Surgery
A Phase 1 study testing Fluorescence spectroscopy guided surgery in people with Low Grade Glioma (LGG) and High Grade Glioma (HGG), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low Grade Glioma (LGG), High Grade Glioma (HGG)
- What is being tested?
- Fluorescence spectroscopy guided surgery
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Clinical signs and history of the disease in favor of a HGG, LGG
- MRI study in favor of a HGG, LGG, meningioma or brain metastasis
- Affiliated to or beneficiary of a social security system (or equivalent).
- Patients who have provided written informed consent for the study
Who cannot join
- Previous life-threatening allergic reactions and known hypersensitivity
- Pregnant or lactating or not using effective contraception;
- Restricted renal function define by a creatinine clearance < 30ml/min
- Patients under a beta-blockers treatment
- Contraindication to do an MRI (pace-maker)
- Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
Show all 9Show fewer
- Minor or adult ward of court (under guardianship or trusteeship)
- No affiliation to a social security system (or equivalent).
- Patients who express opposition to participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.
- Conditions
- Low Grade Glioma (LGG), High Grade Glioma (HGG)
- Being tested
- Fluorescence spectroscopy guided surgery
- Keywords
- glioma, fluorescence spectroscopy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence spectroscopy guided surgeryDevice
A prototype of intraoperative fluorescence spectroscope will be used for fluorescence spectroscopy during a surgical procedure (open surgical approach only). The experimental probe dedicated to the spectroscopic system will be positioned against the surface of the brain, emission spectrum will be acquired and measured, and finally compared with anatomopathology exams. One specific medication will be used as contrast agent in the study: 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative fluorescence spectroscopy | Experimental | The experimental device will be assessed during an open surgical approach for surgical removal of the tumors Receives: Device: Fluorescence spectroscopy guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
The technical feasibility will be assessed by the capacity of the prototype to provide distinguished fluorescence emission spectrum depending on the tumor component (correlation between the spectrum and classical histology).
Measured: 1 day (End of the surgical procedure)
Secondary outcomes (1)
Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events
Safety will be assessed by the number, type and severity of recorded adverse events.
Measured: 14 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Grade Glioma (LGG)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques GUYOTAT, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473380
- Sponsor's protocol ID
- 69HCL14-0270
- Acronym
- GLIOSPECT
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Alston L, Mahieu-Williame L, Hebert M, Kantapareddy P, Meyronet D, Rousseau D, Guyotat J, Montcel B. Spectral complexity of 5-ALA induced PpIX fluorescence in guided surgery: a clinical study towards the discrimination of healthy tissue and margin boundaries in high and low grade gliomas. Biomed Opt Express. 2019 Apr 18;10(5):2478-2492. doi: 10.1364/BOE.10.002478. eCollection 2019 May 1.
PubMed 31149380
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
- ClinicalTrials.gov ID
- NCT02473380
- Acronym / sponsor ID
- GLIOSPECT / 69HCL14-0270
- Conditions
- Low Grade Glioma (LGG), High Grade Glioma (HGG)
- Keywords
- glioma, fluorescence spectroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Jun 2015 (estimated)
- 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.
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative fluorescence spectroscopy | Experimental | Device: Fluorescence spectroscopy guided surgeryThe experimental device will be assessed during an open surgical approach for surgical removal of the tumors |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years old
- Clinical signs and history of the disease in favor of a HGG, LGG
- MRI study in favor of a HGG, LGG, meningioma or brain metastasis
- Affiliated to or beneficiary of a social security system (or equivalent).
- Patients who have provided written informed consent for the study
Key exclusion criteria (9 listed)
- Previous life-threatening allergic reactions and known hypersensitivity
- Pregnant or lactating or not using effective contraception;
- Restricted renal function define by a creatinine clearance < 30ml/min
- Patients under a beta-blockers treatment
- Contraindication to do an MRI (pace-maker)
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 |
|---|---|---|
| Fluorescence spectroscopy guided surgeryA prototype of intraoperative fluorescence spectroscope will be used for fluorescence spectroscopy during a surgical procedure (open surgical approach only). The experimental probe dedicated to the spectroscopic system will be positioned against the surface of the brain, emission spectrum will be acquired and measured, and finally compared with anatomopathology exams. One specific medication will be used as contrast agent in the study: 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight. | Device | Intraoperative fluorescence spectroscopy |
Primary outcome
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
Time frame: 1 day (End of the surgical procedure)
The technical feasibility will be assessed by the capacity of the prototype to provide distinguished fluorescence emission spectrum depending on the tumor component (correlation between the spectrum and classical histology).
1 secondary outcome
Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events
Time frame: 14 days after inclusion
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 19 Dec 2025.
- Results publication: PubMed 31149380Alston L, Mahieu-Williame L, Hebert M, Kantapareddy P, Meyronet D, Rousseau D, Guyotat J, Montcel B. Spectral complexity of 5-ALA induced PpIX fluorescence in guided surgery: a clinical study towards the discrimination of healthy tissue and margin boundaries in high and low grade gliomas. Biomed Opt Express. 2019 Apr 18;10(5):2478-2492. doi: 10.1364/BOE.10.002478. eCollection 2019 May 1.
- Stummer et al. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol 2006 May;7(5):392-401Link provided by the sponsor.
- Jacquesson et al. \[Surgery of high-grade gliomas guided by fluorescence: a retrospective study of 22 patients\]. Neurochirurgie. 2013 Feb;59(1):9-16.Link provided by the sponsor.
- Montcel et al. Two-peaked 5-ALA-induced PpIX fluorescence emission spectrum distinguishes glioblastomas from low grade gliomas and infiltrative component of glioblastomas. Biomed Opt Express. 2013 Apr 1;4(4):548-58Link provided by the sponsor.
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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.
Jacques GUYOTAT, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluorescence spectroscopy guided surgery in people with Low Grade Glioma (LGG) and High Grade Glioma (HGG), run by Hospices Civils de Lyon 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 9 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 19 Dec 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm (time frame: 1 day (End of the surgical procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473380, which also lists 1 linked publication.
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 19 Dec 2025.