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Fluorescence Guided Focal Cortical Dysplasia Surgery (FLUOFOCODYS)

15 juin 2026 mis à jour par: Hospices Civils de Lyon

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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:

  1. To compare the measurement of FCD volume between multimodal high-resolution MRI (HRM) and standard MRI.
  2. To assess the concordance of FCD measurements between multimodal high-resolution MRI (HRM) and standard MRI.
  3. Evaluate the correlation between fluorescence spectroscopy and SpiderMass measurements on the collected tissue sample.
  4. 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.

Type d'étude

Interventionnel

Inscription (Estimé)

5

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
      • Bron, France, 69500
        • Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon
        • Contact:
        • Chercheur principal:
          • Marc GUENOT
      • Bron, France
        • Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
        • Contact:
        • Chercheur principal:
          • Pierre-Aurélien BEURIAT, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Délai: Day 0
Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
Day 0

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
FCD volume in mm3 on standard MRI
Délai: 60 days before Day 0 (=surgery)
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
60 days before Day 0 (=surgery)
FCD volume in mm3 on High Resolution MM- MRI
Délai: Day 0 (=surgery)
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
Day 0 (=surgery)
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI
Délai: 60 days before day 0
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
60 days before day 0
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Délai: Day 0
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
Day 0
Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD
Délai: Day 0
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Day 0
Relative concentration of molecular species measured by SpiderMass on extracted tissue sample of FCD
Délai: Day 0
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Day 0
Number of adverse events
Délai: From the enrollment to day 1
Description of any Adverse Events that have occurred after the experimental treatment until end of study participation
From the enrollment to day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospices Civils de Lyon

Les enquêteurs

  • Chercheur principal: Pierre-Aurélien BEURIAT, Hospices Civils de Lyon

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 69HCL24_0906
  • 2025-523608-64-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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