Glowing dye could help surgeons spot hidden epilepsy lesions
NCT ID NCT07657975
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a fluorescent dye called 5-ALA can help surgeons see and remove abnormal brain tissue in people with drug-resistant epilepsy caused by focal cortical dysplasia (FCD). FCD lesions are often hard to distinguish from healthy brain during surgery, making complete removal difficult. Five participants will receive 5-ALA before surgery, and the surgical team will use a special microscope to detect fluorescence, aiming to improve the precision of the resection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 5-ALA (Gliolan)
- What this could lead to
- If successful, this technique could help surgeons remove more of the epileptic lesion, potentially improving seizure control and reducing the need for medication.
- What could go wrong
- This is a very small pilot study with only 5 patients, so results may not apply to everyone. The approach is still experimental and may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Drug resistant epilepsy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, France
-
Hôpital Neurologique Pierre Wertheimer - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ketamine, long used as an anesthetic, tested as a seizure treatment
- Sound waves aimed at the brain may quiet temporal lobe seizures
- Can a new implant tame seizures when drugs fail?
- Can a High-Fat diet and therapy tame seizures in rare childhood epilepsy?
- Zapping the brain without surgery: a new hope for Tough-to-Treat epilepsy
- Nerve block may cut opioid needs after epilepsy device surgery