Brain imaging on people with partial pharmaco resistant epilepsy
Conditions
Interventions
Product Name: [18F]DPA-714
Product Code: [18F]DPA-714
Pharmaceutical Form: Injection
Sponsors
CEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients with PPRE - over 12 years old the PPRE confirmed having performed a presurgical phase 1 evaluation and where the results have concluded the need for a SEEG - The patient and/or legal representative have given their consent, the child acccepts to participate - TSPO genetic Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Contra-indication to MRI - Pregnant or lactating women or women with no contraception - Patients unable to maintain an elongated, lying flat position for a prolonged period - Patients already included in another study - Patients taking benzodiazepine treatment which could have a confounding affect bon the affinity ot the radiotracer and should be stopped 15 D before the PET
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ;Secondary Objective: - Feasibility and tolerance of the procedure - Efficacy at one year of the surgical procedure in the case of ablation of the fate designated by imaging - Study factors associated with surgery failure versus imaging data - To study the results of the imaging of the patients rejected at the end of the SEEG;Primary end point(s): To evaluate the contribution of PET imaging to 18 F-DPA-714 for the localization of the area responsible for seizures in patients from 12 years of age suffering from pharmaco-resistant partial epilepsy and candidates for surgery during their balance sheet;Timepoint(s) of evaluation of this end point: Percentage of subjects in whom the epileptogenic volume defined by the SEEG performed according to the electrode implantation plan determined with the PET-MRI imaging data has been modified with good reason compared to the implantation plan of the electrodes determined without the multimodal imaging data | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluate the feasibility and the tolerance of the whole procedure. - To evaluate the effectiveness at 1 year of the surgical procedure in case of removal of the designated hearth by imaging. - To study the influence of the "type of epilepsy" (localization, etiology) on the imaging results. - To study the factors associated with the failure of the surgery compared to the data of the imagery. - Compare the resected volume in surgery and the volume defined from the results of the imaging. -Study the imaging results of patients challenged at the end of SEEG. -Conversion of the topography of the 18F-DPA-714 PET imaging data to that of MRI imaging (diffusion tensor and morphological MRI T1 and T2) - Assessment of the impact of epileptic focus on the remote functioning of the brain (functional MRI rest);Timepoint(s) of evaluation of this end point: - Collection and analysis of adverse events and their causal relationship to the entire evaluated procedure. - Number of subjects who benefited from the whole procedure according to the protocol. - Number of seizures in patients 1 year after surgery (ILAE classification). - Study of the results in imaging subgroups of patients according to the type of their epilepsy (the temporal or extra-temporal location, the etiology of their epilepsy, the frequency of seizures). - Imaging data in patients not cured by surgery - Imaging data in patients challenged after SEEG | — |
Countries
France
Contacts
Public ContactBernadette Martins
CEA
Outcome results
None listed