Fluorescence Guided Focal Cortical Dysplasia Surgery (FLUOFOCODYS)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Pierre-Aurélien BEURIAT, MD
- Telefonnummer: +33 4 27 85 62 20
- E-post: pierre-aurelien.beuriat@chu-lyon.fr
Studera Kontakt Backup
- Namn: Clarisse SAUNIER
- Telefonnummer: +33 4 27 85 62 64
- E-post: clarisse.saunier@chu-lyon.fr
Studieorter
-
-
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Bron, Frankrike, 69500
- Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon
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Kontakt:
- Marc GUENOT
- Telefonnummer: +33 4 72 35 71 97
- E-post: marc.guenot@chu-lyon.fr
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Huvudutredare:
- Marc GUENOT
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Bron, Frankrike
- Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
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Kontakt:
- Pierre-Aurélien BEURIAT, MD
- Telefonnummer: +33 4 27 85 62 20
- E-post: pierre.aurelien@chu-lyon.fr
-
Huvudutredare:
- Pierre-Aurélien BEURIAT, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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Patients will be given 5-ALA (20 mg per kilogram body weight) before the surgery, between 2 and 4 hours before anaesthesia.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Tidsram: Day 0
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Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
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Day 0
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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FCD volume in mm3 on standard MRI
Tidsram: 60 days before Day 0 (=surgery)
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Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
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60 days before Day 0 (=surgery)
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FCD volume in mm3 on High Resolution MM- MRI
Tidsram: Day 0 (=surgery)
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Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
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Day 0 (=surgery)
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Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI
Tidsram: 60 days before day 0
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Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
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60 days before day 0
|
|
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Tidsram: Day 0
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Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
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Day 0
|
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Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD
Tidsram: Day 0
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Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
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Day 0
|
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Relative concentration of molecular species measured by SpiderMass on extracted tissue sample of FCD
Tidsram: Day 0
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Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
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Day 0
|
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Number of adverse events
Tidsram: From the enrollment to day 1
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Description of any Adverse Events that have occurred after the experimental treatment until end of study participation
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From the enrollment to day 1
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Pierre-Aurélien BEURIAT, Hospices Civils de Lyon
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Medfödda abnormiteter
- Missbildningar av kortikal utveckling, grupp I
- Missbildningar av kortikal utveckling
- Missbildningar i nervsystemet
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Läkemedelsresistent epilepsi
- Fokal kortikal dysplasi
- Epilepsi
Andra studie-ID-nummer
- 69HCL24_0906
- 2025-523608-64-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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