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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Pierre-Aurélien BEURIAT, MD
- Telefonnummer: +33 4 27 85 62 20
- E-post: pierre-aurelien.beuriat@chu-lyon.fr
Studer Kontakt Backup
- Navn: Clarisse SAUNIER
- Telefonnummer: +33 4 27 85 62 64
- E-post: clarisse.saunier@chu-lyon.fr
Studiesteder
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Bron, Frankrike, 69500
- Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon
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Ta kontakt med:
- Marc GUENOT
- Telefonnummer: +33 4 72 35 71 97
- E-post: marc.guenot@chu-lyon.fr
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Hovedetterforsker:
- Marc GUENOT
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Bron, Frankrike
- Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
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Ta kontakt med:
- Pierre-Aurélien BEURIAT, MD
- Telefonnummer: +33 4 27 85 62 20
- E-post: pierre.aurelien@chu-lyon.fr
-
Hovedetterforsker:
- Pierre-Aurélien BEURIAT, MD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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FCD volume in mm3 on standard MRI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Pierre-Aurélien BEURIAT, Hospices Civils de Lyon
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Medfødte abnormiteter
- Misdannelser av kortikal utvikling, gruppe I
- Misdannelser av kortikal utvikling
- Misdannelser i nervesystemet
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Medikamentresistent epilepsi
- Fokal kortikal dysplasi
- Epilepsi
Andre studie-ID-numre
- 69HCL24_0906
- 2025-523608-64-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
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