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Fluorescence Guided Focal Cortical Dysplasia Surgery (FLUOFOCODYS)

15 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

5

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Periodo de tiempo: Day 0
Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
Day 0

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
FCD volume in mm3 on standard MRI
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Day 0
Number of adverse events
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospices Civils de Lyon

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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