Drug Resistant EpilepsyPhase 2FLUOFOCODYSNCT07657975
Fluorescence Guided Focal Cortical Dysplasia Surgery
A Phase 2 study testing 5-ALA (Gliolan) in people with Drug Resistant Epilepsy, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant epilepsy (RPE). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- 5-ALA (Gliolan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with drug resistant epilepsy, related to a type II FCD visible on MRI
- Patient with surgical indication validated by the epileptic multi-disciplinary staff meeting
- First FCD surgery
- Signed written informed consent before any study specific intervention
- Patient affiliated to the national health system or benefiting from it
Who cannot join
- Patients weighing over 75kg
- Patients requiring general anaesthesia for MRI at investigator discretion
- Contra indication to MRI : obesity, claustrophobia, metallic object
- Hypersensitivity to the active substance or to porphyrins
- Acute or chronic porphyria
- For woman of childbearing potential: Pregnancy or breastfeeding or patients who is not willing to comply with the contraceptive requirements during the study period
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- Inability to follow the procedures of the study
- Simultaneous enrolment to another study which could influence the results of the current study
- Patient under legal protection or deprived of liberty
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500
Marc GUENOT, 4 72 35 71 97 ext. +33, marc.guenot@chu-lyon.fr
Marc GUENOT
Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron
Pierre-Aurélien BEURIAT, MD, 4 27 85 62 20 ext. +33, pierre.aurelien@chu-lyon.fr
Pierre-Aurélien BEURIAT, MD
About this study
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant epilepsy (RPE). The onset of RPE can be lengthy, prolonging the period during which affected patients live with seizures that have a negative impact on their quality of life. Epilepsy surgery can be a curative treatment, and can enable anticonvulsant medication to be discontinued, optimizing quality of life and cognitive development. In addition, as it has been shown that the prolonged duration of epilepsy prior to surgery has an impact on the occurrence of postoperative seizures, early surgery is increasingly being considered. Focal cortical dysplasia (FCD) is the leading cause of focal lesional epilepsy and is generally drug-resistant. Good postoperative seizure results after surgical resection are strongly linked to complete resection of the dysplastic tissue. Consequently, accurate localization and precise delineation of FCD lesions are crucial during surgery. Currently, the extent of surgical resection is based primarily on preoperative examination, as the macroscopic appearance of dysplastic tissue does not differ from normal cortex. The various intraoperative techniques available to improve the quality of excision (neuronavigation, ultrasound, intraoperative MRI and intraoperative guidance by fluorescence microscopy) all have their limitations. In this context, new intraoperative tools are needed to help the neurosurgeon delineate lesions during surgery. Intraoperative fluorescence spectroscopy is used for surgical guidance of gliomas and other brain pathologies, and has demonstrated its ability to characterize pathological tissues. DCFs exhibit metabolic differences that can also be detected by 5-amino-levulinic acid (5-ALA)-induced protoporphyrin IX (PpIX) fluorescence intraoperatively. Indeed, in some patients who underwent surgery after a diagnosis of glioma, fluorescence was observed even though histological analysis classified the excised tissue as DCF. What's more, glioma and DCF share a common feature: the mitochondria of affected cells are deficient in complex IV. Cytochrome c oxidase (CCO) is largely involved in mitochondrial complex IV, and NAD is a central metabolite involved in redox reactions within cells. Both metabolites (CCO and NAD) can be visualized intraoperatively by optical and fluorescence spectroscopy.
FLUOFOCODYS is a prospective, non-comparative, single-center, human drug pilot clinical trial. 5 patients will be included.
Read the detailed description
Primary objective of FLUOFOCODYS study is to measure the fluorescence of biomarkers of focal epileptic lesions by intraoperative fluorescence spectroscopy.
The secondary objectives are as follows:
- To compare the measurement of FCD volume between multimodal high-resolution MRI (HRM) and standard MRI.
- To assess the concordance of FCD measurements between multimodal high-resolution MRI (HRM) and standard MRI.
- Evaluate the correlation between fluorescence spectroscopy and SpiderMass measurements on the collected tissue sample.
- Describe any adverse events that occurred after treatment up to the end of study participation.
The hypothesis of this project is that intraoperative fluorescence spectroscopy could robustly measure 5-ALA-induced protoporphyrin IX fluorescence in FCD and could ultimately aid FCD surgery. Thus, to understand intraoperative biomarker fluorescence spectroscopy in DCF, preoperative MRI and postoperative histology are crucial. This will enable MRI-informed intraoperative fluorescence spectroscopy. These comparative measurements will be completed with SpiderMass technology (metabo-lipidomic mass spectrometry). The effectiveness of intraoperative tools could therefore be assessed prior to surgery, which could have an impact on the therapeutic decision to proceed with surgery.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- 5-ALA (Gliolan)
- Keywords
- Epilepsy, Focal Cortical Dysplasia, Intraoperative Fluorescence Spectroscopy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Focal Cortical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ALA (Gliolan)Drug
Patients will be given 5-ALA (20 mg per kilogram body weight) before the surgery, between 2 and 4 hours before anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA (Gliolan) | Experimental | Children and adults with drug resistant epilepsy, related to a probable FCD and with surgical indication validated by the epileptic multi-disciplinary staff meeting will receive the study treatment (5-ALA) orally at a dose of 20mg/kg Receives: Drug: 5-ALA (Gliolan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
Measured: Day 0
Secondary outcomes (7)
FCD volume in mm3 on standard MRI
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
Measured: 60 days before Day 0 (=surgery)
FCD volume in mm3 on High Resolution MM- MRI
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
Measured: Day 0 (=surgery)
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
Measured: 60 days before day 0
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
Measured: Day 0
Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Measured: Day 0
Relative concentration of molecular species measured by SpiderMass on extracted tissue sample of FCD
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Measured: Day 0
Number of adverse events
Description of any Adverse Events that have occurred after the experimental treatment until end of study participation
Measured: From the enrollment to day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot, prospective, non-comparative and monocentric clinical drug trial on medicinal product for human use.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Aurélien BEURIAT, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657975
- Sponsor's protocol ID
- 69HCL24_0906
- Other IDs
- 2025-523608-64-00, 2025
- Acronym
- FLUOFOCODYS
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Guided Focal Cortical Dysplasia Surgery
- ClinicalTrials.gov ID
- NCT07657975
- Acronym / sponsor ID
- FLUOFOCODYS / 69HCL24_0906
- Conditions
- Drug Resistant Epilepsy
- Keywords
- Epilepsy, Focal Cortical Dysplasia, Intraoperative Fluorescence Spectroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant epilepsy (RPE). The onset of RPE can be lengthy, prolonging the period during which affected patients live with seizures that have a negative impact on their quality of life. Epilepsy surgery can be a curative treatment, and can enable anticonvulsant medication to be discontinued, optimizing quality of life and cognitive development. In addition, as it has been shown that the prolonged duration of epilepsy prior to surgery has an impact on the occurrence of postoperative seizures, early surgery is increasingly being considered. Focal cortical dysplasia (FCD) is the leading cause of focal lesional epilepsy and is generally drug-resistant. Good postoperative seizure results after surgical resection are strongly linked to complete resection of the dysplastic tissue. Consequently, accurate localization and precise delineation of FCD lesions are crucial during surgery. Currently, the extent of surgical resection is based primarily on preoperative examination, as the macroscopic appearance of dysplastic tissue does not differ from normal cortex. The various intraoperative techniques available to improve the quality of excision (neuronavigation, ultrasound, intraoperative MRI and intraoperative guidance by fluorescence microscopy) all have their limitations. In this context, new intraoperative tools are needed to help the neurosurgeon delineate lesions during surgery. Intraoperative fluorescence spectroscopy is used for surgical guidance of gliomas and other brain pathologies, and has demonstrated its ability to characterize pathological tissues. DCFs exhibit metabolic differences that can also be detected by 5-amino-levulinic acid (5-ALA)-induced protoporphyrin IX (PpIX) fluorescence intraoperatively. Indeed, in some patients who underwent surgery after a diagnosis of glioma, fluorescence was observed even though histological analysis classified the excised tissue as DCF. What's more, glioma and DCF share a common feature: the mitochondria of affected cells are deficient in complex IV. Cytochrome c oxidase (CCO) is largely involved in mitochondrial complex IV, and NAD is a central metabolite involved in redox reactions within cells. Both metabolites (CCO and NAD) can be visualized intraoperatively by optical and fluorescence spectroscopy.
FLUOFOCODYS is a prospective, non-comparative, single-center, human drug pilot clinical trial. 5 patients will be included.
Detailed description
Primary objective of FLUOFOCODYS study is to measure the fluorescence of biomarkers of focal epileptic lesions by intraoperative fluorescence spectroscopy.
The secondary objectives are as follows:
- To compare the measurement of FCD volume between multimodal high-resolution MRI (HRM) and standard MRI.
- To assess the concordance of FCD measurements between multimodal high-resolution MRI (HRM) and standard MRI.
- Evaluate the correlation between fluorescence spectroscopy and SpiderMass measurements on the collected tissue sample.
- Describe any adverse events that occurred after treatment up to the end of study participation.
The hypothesis of this project is that intraoperative fluorescence spectroscopy could robustly measure 5-ALA-induced protoporphyrin IX fluorescence in FCD and could ultimately aid FCD surgery. Thus, to understand intraoperative biomarker fluorescence spectroscopy in DCF, preoperative MRI and postoperative histology are crucial. This will enable MRI-informed intraoperative fluorescence spectroscopy. These comparative measurements will be completed with SpiderMass technology (metabo-lipidomic mass spectrometry). The effectiveness of intraoperative tools could therefore be assessed prior to surgery, which could have an impact on the therapeutic decision to proceed with surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot, prospective, non-comparative and monocentric clinical drug trial on medicinal product for human use.
| Arm | Type | Receives |
|---|---|---|
| 5-ALA (Gliolan) | Experimental | Drug: 5-ALA (Gliolan)Children and adults with drug resistant epilepsy, related to a probable FCD and with surgical indication validated by the epileptic multi-disciplinary staff meeting will receive the study treatment (5-ALA) orally at a dose of 20mg/kg |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with drug resistant epilepsy, related to a type II FCD visible on MRI
- Patient with surgical indication validated by the epileptic multi-disciplinary staff meeting
- First FCD surgery
- Signed written informed consent before any study specific intervention
- Patient affiliated to the national health system or benefiting from it
Key exclusion criteria (9 listed)
- Patients weighing over 75kg
- Patients requiring general anaesthesia for MRI at investigator discretion
- Contra indication to MRI : obesity, claustrophobia, metallic object
- Hypersensitivity to the active substance or to porphyrins
- Acute or chronic porphyria
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 |
|---|---|---|
| 5-ALA (Gliolan)Patients will be given 5-ALA (20 mg per kilogram body weight) before the surgery, between 2 and 4 hours before anaesthesia. | Drug | 5-ALA (Gliolan) |
Primary outcome
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Time frame: Day 0
Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
7 secondary outcomes
FCD volume in mm3 on standard MRI
Time frame: 60 days before Day 0 (=surgery)
FCD volume in mm3 on High Resolution MM- MRI
Time frame: Day 0 (=surgery)
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI
Time frame: 60 days before day 0
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Time frame: Day 0
Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD
Time frame: Day 0
Relative concentration of molecular species measured by SpiderMass on extracted tissue sample of FCD
Time frame: Day 0
Number of adverse events
Time frame: From the enrollment to day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pierre-Aurélien BEURIAT principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-ALA (Gliolan) in people with Drug Resistant Epilepsy, run by Hospices Civils de Lyon at 2 sites 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Aurélien BEURIAT, MD (4 27 85 62 20 ext. +33, pierre-aurelien.beuriat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD (time frame: Day 0). 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 18 Jun 2026.