Status:
NOT_YET_RECRUITING
Innovative MRI to Localize the Epileptic Zone
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
University Grenoble Alps
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Epilepsy, Temporal Lobe
Eligibility:
All Genders
18-65 years
Brief 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 t...
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 res...
Eligibility Criteria
Inclusion
- 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
- Reference group
- Male or female, 18-65 years,
- Obtained signed informed consent from participants,
- Negative pregnancy test for child-bearing aged woman
Exclusion
- 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),
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06057233
Start Date
October 1 2024
End Date
November 1 2028
Last Update
August 23 2024
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