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Glowing dye could help surgeons spot hidden epilepsy lesions

NCT ID NCT07657975

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy epilepsy Focal Cortical Dysplasia isolated focal cortical dysplasia type II

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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