Epilepsy (Treatment Refractory)CEST-BESTNCT07316972
CEST-based Biomarkers to Delineate the Epileptogenic Zone
A study testing CEST sequence on a 7-Tesla MRI in people with Epilepsy (Treatment Refractory), run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Epilepsy is a common neurological disorder with an incidence of 1%. Although many anti-seizure medications are available, about 30% of patients are resistant to drug treatments. Epilepsy surgery is an effective treatment for some of these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy (Treatment Refractory)
- What is being tested?
- CEST sequence on a 7-Tesla MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with drug-resistant temporal lobe epilepsy (mesial or lateral)
- Requiring a pre-surgical evaluation including long-term video EEG
- At least 5 of them will be recruited after surface video EEG indicates the need for further exploration by SEEG
- With or without a radiologically visible lesion
Who cannot join
- Absolute or relative contraindication to MRI (metallic implants, including intrauterine devices other than the MIRENA® brand, claustrophobia, etc.)
- Expected inability to remain still for 90 minutes in a 7T MRI
- Diabetic individuals
- Individuals under legal protection measures
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Epilepsy is a common neurological disorder with an incidence of 1%. Although many anti-seizure medications are available, about 30% of patients are resistant to drug treatments. Epilepsy surgery is an effective treatment for some of these patients. It involves removing the brain region responsible for generating seizures, called the epileptogenic zone (EZ).
A pre-surgical evaluation is performed to locate and delineate the region where seizures originate (the seizure onset zone [SOZ]) and to confirm that this zone is unique and accessible for surgery-that is, that the potential benefits outweigh the risks of functional deficits resulting from its removal. The lesion itself is identified and characterized through post-operative histological examination and, in some cases, based on MRI criteria.
Read more
During pre-surgical evaluation, in cases where no lesion is visible on MRI or when surface EEG suggests that a large or multiple epileptic networks may be involved, stereo-electroencephalography (SEEG) is the method of choice to delineate the area for resection. However, SEEG has limitations: it is invasive and records from a restricted brain volume.
Despite advances in neuroimaging techniques, the localization of the epileptogenic zone and mapping of functional brain alterations still need improvement beyond what morphological MRI anomalies can reveal.
Because epileptic tissue is characterized by increased neuronal excitability and metabolic abnormalities, techniques that allow precise evaluation of these changes could deepen our understanding of the disease and provide new tools for epilepsy surgery. An alternative MRI approach based on metabolite quantification using chemical exchange saturation transfer (CEST) has been suggested to aid in localizing the epileptogenic zone in preliminary studies. However, limited availability of ultra-high-field MRI, low localization precision of the epileptogenic zone, and lack of systematic validation in patients have delayed its clinical use.
This study aims to explore a cohort of patients with temporal lobe epilepsy who are candidates for surgery using CEST MRI. We will quantify glutamate and glucose concentrations using glu-CEST and gluco-CEST, respectively, and correlate the results with the localization of the epileptogenic zone determined by pre-surgical evaluation, and where applicable, SEEG and post-operative outcomes.
- Conditions
- Epilepsy (Treatment Refractory)
- Being tested
- CEST sequence on a 7-Tesla MRI
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEST sequence on a 7-Tesla MRIOther
CEST sequence on a 7-Tesla MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled to undergo a pre-surgical evaluation for drug-resistant epilepsy. | Experimental | Not described Receives: Other: CEST sequence on a 7-Tesla MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration measured by CEST in the the seizure onset zone (SOZ)
Measured: Day 0
Secondary outcomes (5)
Glucose concentration measured by CEST in the irritative zone (IZ)
Measured: Day 0
Glucose concentration measured by CEST in the propagation zone
Measured: Day 0
Glutamate concentration measured by CEST in the seizure onset zone (SOZ)
Measured: Day 0
Glutamate concentration measured by CEST in the irritative zone (IZ)
Measured: Day 0
Glutamate concentration measured by CEST in the propagation zone
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316972
- Sponsor's protocol ID
- MQS_2024_10
- Acronym
- CEST-BEST
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No