Epilepsy, Temporal LobeEPI-CATCHERNCT06057233
Innovative MRI to Localize the Epileptic Zone
An observational study of Epilepsy, Temporal Lobe, run by University Hospital, Grenoble.
Trial summary
The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- mqMRI and GABA-MRS
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 : patients with MTLE epilepsy, candidate to resection surgery Group 2 : healthy volunteers, to obtain reference mqMRI and GABA-MRS values
Who may be able to join
- Patient group
- Patients aged 18-65 years,
- Patients with drug-resistant focal epilepsy,
- Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,
- Negative pregnancy test for child-bearing aged woman,
- Obtained signed informed consent from patient
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- Reference group
- Male or female, 18-65 years,
- Obtained signed informed consent from participants,
- Negative pregnancy test for child-bearing aged woman
Who cannot join
- Patient group
- Patient without social security system
- Inability or unwillingness of the individual to provide written informed consent, according to national regulations.
- Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
- Contraindication for MRI,
- Contraindication for injection of MRI contrast agent (Gd-Chelate),
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- Evidence on neuroimaging (CT or MRI) of a brain lesion in the same hemisphere as the EZ (tumor, stroke, cerebral edema with midline shift and a clinically significant compression of ventricles, or subarachnoid hemorrhage, or intracerebral parenchymal hematoma (petechial small hemorrhages are NOT a non-inclusion criteria),
- Severe leucoariosis
- Pre-existing dementia
- Pregnant, breastfeeding women
- Reference group
- Person who is participating in another therapeutic trial
- Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts
- Person without social security system,
- Inability or unwillingness of the individual to provide written informed consent, according to national regulations,
- Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
- Contraindication for MRI
- Contraindication for injection of MRI contrast agent (Gd-Chelate)
- Pregnant, breastfeeding woman.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emmanuel L Barbier, PhD contact
About this study
Official title: Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone
The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ.
Read the detailed description
After informed consent, patient candidate to resection surgery will undergo two extra MRI sessions before surgery: one for multiparametric quantitative MRI (mqMRI) and one for GABA-edited magnetic resonance spectroscopy (GABA-MRS) In parallel, a group of healthy volunteers will also undergo the two MRI sessions described above, to collect reference data.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- mqMRI and GABA-MRS
- Keywords
- MRI, Quantitative, GABA, MRS
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mqMRI and GABA-MRSDiagnostic test
multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)
| Study group | Role | What they receive |
|---|---|---|
| Patients | mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy Receives: Diagnostic Test: mqMRI and GABA-MRS | |
| Volunteers | mqMRI and GABA-MRS data will be collected in healthy volunteers Receives: Diagnostic Test: mqMRI and GABA-MRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
EZmri vs EZsdt
The correlation coefficient between the Dice similarity coefficient (= 2 * the Area of Overlap between EZMRI and EZsdt divided by the total number of pixels in EZMRI and EZsdt) and the reduction in seizure frequency (= seizure frequency one year after surgery / seizure frequency at inclusion).
Measured: 5 years
Secondary outcomes (6)
mqMRI : T1 (ms)
Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers
Measured: 5 years
mqMRI : T2 (ms)
Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers
Measured: 5 years
mqMRI : Mean Diffusivity (s/mm²)
Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers
Measured: 5 years
mqMRI : Cerebral Blood Volume (%)
Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers
Measured: 5 years
mqMRI : Blood-Brain Barrier Permeability (%)
Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers
Measured: 5 years
GABA
Compare, for each patient, the amplitude of GABA and other metabolites available using proton MRS (N-acetyl aspartate and N-acetyl-aspartyl-glutamate (NAA) Creatine and phosphocreatine (Cr), Choline (Cho), Myo-inositol, myo-inositol-monophosphate and glycine (mI), Glutamine (Gln), glutamate (Glu), Lipids (LipX), Lactate (Lac)) in the EZsdt with the mean values obtained in the same region across the healthy volunteers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startOct 2024 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Philippe Kahane, MD, PhD, Principal investigator, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057233
- Sponsor's protocol ID
- 38RC22.0265_EPI-CATCHER
- Other IDs
- ANR-21-CE17-0031, 2022-A01949-34
- Acronym
- EPI-CATCHER
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boux F, Forbes F, Collomb N, Zub E, Maziere L, de Bock F, Blaquiere M, Stupar V, Depaulis A, Marchi N, Barbier EL. Neurovascular multiparametric MRI defines epileptogenic and seizure propagation regions in experimental mesiotemporal lobe epilepsy. Epilepsia. 2021 May;62(5):1244-1255. doi: 10.1111/epi.16886. Epub 2021 Apr 5.
PubMed 33818790Hamelin S, Stupar V, Maziere L, Guo J, Labriji W, Liu C, Bretagnolle L, Parrot S, Barbier EL, Depaulis A, Fauvelle F. In vivo gamma-aminobutyric acid increase as a biomarker of the epileptogenic zone: An unbiased metabolomics approach. Epilepsia. 2021 Jan;62(1):163-175. doi: 10.1111/epi.16768. Epub 2020 Dec 1.
PubMed 33258489
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone
- ClinicalTrials.gov ID
- NCT06057233
- Acronym / sponsor ID
- EPI-CATCHER / 38RC22.0265_EPI-CATCHER
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- MRI, Quantitative, GABA, MRS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ.
Detailed description
After informed consent, patient candidate to resection surgery will undergo two extra MRI sessions before surgery: one for multiparametric quantitative MRI (mqMRI) and one for GABA-edited magnetic resonance spectroscopy (GABA-MRS) In parallel, a group of healthy volunteers will also undergo the two MRI sessions described above, to collect reference data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: mqMRI and GABA-MRSmqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy |
| Volunteers | – | Diagnostic Test: mqMRI and GABA-MRSmqMRI and GABA-MRS data will be collected in healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 : patients with MTLE epilepsy, candidate to resection surgery Group 2 : healthy volunteers, to obtain reference mqMRI and GABA-MRS values
Key inclusion criteria (10 listed)
- Patient group
- Reference group
Key exclusion criteria (19 listed)
- Patient group
- Reference group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mqMRI and GABA-MRSmultiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS) | Diagnostic test | Patients, Volunteers |
Primary outcome
EZmri vs EZsdt
Time frame: 5 years
The correlation coefficient between the Dice similarity coefficient (= 2 * the Area of Overlap between EZMRI and EZsdt divided by the total number of pixels in EZMRI and EZsdt) and the reduction in seizure frequency (= seizure frequency one year after surgery / seizure frequency at inclusion).
6 secondary outcomes
mqMRI : T1 (ms)
Time frame: 5 years
mqMRI : T2 (ms)
Time frame: 5 years
mqMRI : Mean Diffusivity (s/mm²)
Time frame: 5 years
mqMRI : Cerebral Blood Volume (%)
Time frame: 5 years
mqMRI : Blood-Brain Barrier Permeability (%)
Time frame: 5 years
GABA
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 33818790Boux F, Forbes F, Collomb N, Zub E, Maziere L, de Bock F, Blaquiere M, Stupar V, Depaulis A, Marchi N, Barbier EL. Neurovascular multiparametric MRI defines epileptogenic and seizure propagation regions in experimental mesiotemporal lobe epilepsy. Epilepsia. 2021 May;62(5):1244-1255. doi: 10.1111/epi.16886. Epub 2021 Apr 5.
- Background: PubMed 33258489Hamelin S, Stupar V, Maziere L, Guo J, Labriji W, Liu C, Bretagnolle L, Parrot S, Barbier EL, Depaulis A, Fauvelle F. In vivo gamma-aminobutyric acid increase as a biomarker of the epileptogenic zone: An unbiased metabolomics approach. Epilepsia. 2021 Jan;62(1):163-175. doi: 10.1111/epi.16768. Epub 2020 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel L Barbier, PhD contact
Philippe Kahane, MD, PhD principal investigator
University Grenoble Alps
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Temporal Lobe, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie Miquel, MSc (+33 4 76 76 63 08, lmiquel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EZmri vs EZsdt (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06057233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.