Evaluation of 18F-DPA-714 PET-MRI imaging for locating epileptic focus in patients with drug-resistant partial epilepsy before surgery

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What is this study about?

This study focuses on patients with drug-resistant epilepsy who have not responded to at least two different medications and are being considered for surgery. The study uses a special imaging substance called 18F-DPA-714 that is given through an intravenous injection. This substance is used during combined PET-MRI scanning to help doctors better locate the exact area in the brain where seizures begin.

The purpose of this research is to determine how helpful this new imaging method is in identifying the precise location of brain tissue causing seizures before surgery. During the study, participants will receive the imaging substance and undergo a combined PET and MRI scan. This advanced imaging technique could help surgeons better plan the placement of monitoring devices called SEEG (stereoelectroencephalography) electrodes, which are used to confirm the location of seizure activity.

The imaging procedure combines two different types of scans: PET (Positron Emission Tomography) scanning, which uses the special imaging substance to show areas of inflammation in the brain, and MRI (Magnetic Resonance Imaging), which provides detailed pictures of brain structure. This combination may provide better information about the location of seizure-causing areas compared to current standard imaging methods.

1 Initial PET-MRI scan preparation

You will undergo a combined PET-MRI scan to help locate the source of seizures in your brain

The imaging procedure involves receiving an injection of 18F-DPA-714, a special substance that helps visualize brain activity

The substance will be administered through an intravenous injection into your vein

2 Imaging procedure

You will lie still while the combined PET and MRI machines create detailed images of your brain

The imaging helps identify the exact areas causing seizures

Medical staff will monitor you throughout the procedure

3 SEEG procedure planning

The medical team will use the PET-MRI results to plan the placement of SEEG (stereoelectroencephalography) electrodes

SEEG involves placing thin electrodes in specific brain areas to record electrical activity

The imaging helps determine the most precise locations for electrode placement

4 Follow-up monitoring

Your progress will be monitored for one year after the surgical procedure

The medical team will track the number and frequency of seizures during this period

Regular check-ups will assess your response to the treatment

Who Can Join the Study?

You must have drug-resistant epilepsy (epilepsy that continues after trying two different properly administered treatments)
You can be either male or female
You must be 12 years of age or older
You must have undergone a pre-surgical assessment (initial evaluation before surgery) that shows you need a SEEG (stereoelectroencephalography – a procedure where electrodes are placed in the brain to locate the source of seizures)
Your epilepsy must be partial (seizures that start in one specific area of the brain)
If participating as a healthy volunteer:
- Must be healthy with no chronic or progressive medical conditions
- Must be between 18 and 55 years old
- Can be male or female
- Must have social security coverage

Who Cannot Join the Study?

Patients under 12 years old cannot participate in the study
Patients who are not diagnosed with drug-resistant epilepsy (epilepsy that does not respond well to medication)
Patients who are not candidates for SEEG (stereoelectroencephalography – a surgical procedure where electrodes are placed in the brain to monitor seizure activity)
Patients who are pregnant or breastfeeding
Patients who have had brain surgery in the past
Patients who cannot undergo PET imaging (a type of medical scan that uses a special radioactive substance)
Patients who are unable to provide informed consent
Patients with known allergies to the study medication (18F-DPA-714)
Patients participating in other clinical trials
Patients with severe medical conditions that could interfere with the study procedures

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
French Alternative Energies And Atomic Energy Commision	Orsay	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.11.2018

Trial locations

Investigated drugs:

N,N-Diethyl-2-(2-(4-(2[(18)F]-Fluoroethoxy)Phenyl)5,7Dimethylpyrazolo[1,5A]Pyrimidin-3-Yl)Acetamide

18F-DPA714 is a radioactive tracer used in PET (Positron Emission Tomography) imaging. When injected into the body, it helps doctors see areas of inflammation in the brain that might be related to epilepsy. This tracer specifically binds to activated microglia (brain immune cells) that are often present in areas where seizures start. The imaging technique combines PET scanning with MRI to create detailed pictures that can help surgeons identify exactly where to operate in patients with drug-resistant epilepsy.

Investigated diseases:

Epilepsy

Drug-resistant epilepsy – A condition where seizures continue to occur despite treatment with appropriate anti-seizure medications. The brain develops resistance to medications that normally control seizures, making standard treatments less effective. Patients experience recurrent seizures that can vary in type, frequency, and severity. This form of epilepsy involves abnormal electrical activity in specific areas of the brain that cannot be adequately controlled through conventional medical therapy. The condition typically persists over time and may affect various aspects of daily life. The seizures can originate from one or multiple areas of the brain, with patterns that remain consistent for each individual.

Trial ID:

2024-517638-16-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Evaluation of 18F-DPA-714 PET-MRI imaging for locating epileptic focus in patients with drug-resistant partial epilepsy before surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?