Fluorescence Guided Focal Cortical Dysplasia Surgery

NCT07657975 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 69HCL24_09062025-523608-64-00
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Drug Resistant Epilepsy

Keywords

Epilepsy; Focal Cortical Dysplasia; Intraoperative Fluorescence Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (7)

• FCD volume in mm3 on standard MRI

  60 days before Day 0 (=surgery)

• FCD volume in mm3 on High Resolution MM- MRI

  Day 0 (=surgery)

• Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI

  60 days before day 0

• Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI

  Day 0

• Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD

  Day 0

Study Arms (1)

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

Drug: 5-ALA (Gliolan)

Interventions

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.

5-ALA (Gliolan)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon

Bron, 69500, France

Location

Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon

Bron, France

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Focal Cortical Dysplasia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pierre-Aurélien BEURIAT

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Aurélien BEURIAT, MD

CONTACT

4 27 85 62 20; pierre-aurelien.beuriat@chu-lyon.fr

Clarisse SAUNIER

CONTACT

4 27 85 62 64; clarisse.saunier@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, prospective, non-comparative and monocentric clinical drug trial on medicinal product for human use.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

FR (2)