Fluorescence Guided Focal Cortical Dysplasia Surgery

Starting soon · Phase 2

Conditions studied: Drug Resistant Epilepsy

In brief

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.

Key facts

Study ID: NCT07657975
Run by: Hospices Civils de Lyon
People needed: 5
Starts: 2026-09-01
Expected to finish: 2028-09-01
Last updated by the study team: 2026-06-18

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon — Bron, France
Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon — Bron, France

Full record on ClinicalTrials.gov

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