Study in 18F-DPA714 PET to better locate preoperatively the epileptic focus to resect in drug-resistant partial epilepsy

Phase 1

Conditions: Brain imaging on people with partial pharmaco resistant epilepsy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-003381-27-FR

Lead Sponsor: CEA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ;Secondary Objective: - Feasibility and tolerance of the procedure<br>- Efficacy at one year of the surgical procedure in the case of ablation of the fate designated by imaging<br>- Study factors associated with surgery failure versus imaging data<br>- 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 Outcome Measures