N,N-DIETHYL-2-(2-(4-(2[(18)F]-FLUOROETHOXY)PHENYL)5,7DIMETHYLPYRAZOLO[1,5A]PYRIMIDIN-3-YL)ACETAMIDE for Drug-resistant partial epilepsy

Inclusion criteria

• {"criterion_text":"- FOR PATIENTS: Patients with drug-resistant epilepsy (whose epilepsy epilepsy persists after two types of well-conducted treatment).\n- FOR PATIENTS: Male or female .\n- FOR PATIENTS: Age : ≥ 12 years\n- FOR PATIENTS: Patients with drug-resistant partial epilepsy who have undergone a pre-surgical assessment or phase 1 , the results of which necessitate the use of a SEEG\n- FOR HEALTHY VOLUNTEER: Healthy volunteers (i.e. no chronic and/or progressive general pathology)\n- FOR HEALTHY VOLUNTEER: Male or female\n- FOR HEALTHY VOLUNTEER: Age: ≥ 18 years and up to 55 years\n- FOR HEALTHY VOLUNTEER: Social security"}

Exclusion criteria

• {"criterion_text":"- FOR PATIENTS: Any contraindication to MRI.\n- FOR PATIENTS: Pregnant or lactating women, or those not using effective contraception.\n- FOR PATIENTS: Lying position impossible to maintain for long periods.\n- FOR PATIENTS: Treatment with benzodiazepines such as flunitrazepam, triazolam, diazepam, which may have a moderate affinity for TSPO, be prohibited and must be discontinued at least 15 days before inclusion in the study. Clonazepam, lorazepam, zolpidem, and zopiclone, which have a very low affinity for TSPO, will be tolerated tolerated like other GABA A receptor-modulating antiepileptics.\n- FOR PATIENTS: Patients already included in another therapeutic trial using radioactivity.\n- FOR HEALTHY VOLUNTEER: Any contraindication to MRI\n- FOR HEALTHY VOLUNTEER: Women who are pregnant, lactating or not using an effective method of contraception\n- FOR HEALTHY VOLUNTEER: Lying position impossible to maintain for long periods\n- FOR HEALTHY VOLUNTEER: Subject excluded from a medical research protocol."}

Primary endpoints

• {"endpoint_text":"- Percentage of subjects in whom the epileptogenic volume defined by SEEG performed according to the electrode implantation plan determined with multimodal PET-MRI imaging (VE2) will have been correctly modified compared with the electrode implantation plan determined without multimodal imaging data (VE1).","definition_or_measurement_approach":"Measured as the percentage of subjects whose electrode implantation plan (SEEG) is correctly modified when based on multimodal PET-MRI imaging (VE2) compared with the plan determined without multimodal imaging (VE1)."}

Secondary endpoints

• {"endpoint_text":"- Collection and analysis of adverse events and their causal relationship in relation to the entire procedure evaluated.","definition_or_measurement_approach":"Collection and analysis of adverse events and assessment of causal relationship with the entire imaging/surgical procedure."}
• {"endpoint_text":"- Number of subjects who benefited from the entire procedure in accordance with the protocol.","definition_or_measurement_approach":"Number/count of subjects who completed the entire procedure per protocol."}
• {"endpoint_text":"- Number of seizures in patients 1 year after surgery (ILAE classification).","definition_or_measurement_approach":"Count of seizures at 1 year post-surgery, classified using the ILAE classification."}
• {"endpoint_text":"- Study of imaging results in subgroups of patients according to the type epilepsy (temporal or extra-temporal localization, etiology of epilepsy epilepsy, seizure frequency).","definition_or_measurement_approach":"Subgroup analyses of imaging outcomes by epilepsy type (temporal vs extratemporal), etiology, and seizure frequency."}
• {"endpoint_text":"- Imaging data in patients not cured by surgery.","definition_or_measurement_approach":"Analysis of imaging findings among patients who are not cured by surgical intervention."}
• {"endpoint_text":"- Imaging data in patients rejected after SEEG.","definition_or_measurement_approach":"Analysis of imaging results for patients deemed not suitable after SEEG."}
• {"endpoint_text":"- Topography of PET imaging data 18F-DPA-714 PET vs. MRI data.","definition_or_measurement_approach":"Comparison of spatial/topographic data between 18F-DPA-714 PET imaging and MRI modalities (DTI, T1, T2)."}
• {"endpoint_text":"- Relationship between epileptic focus and remote brain function.","definition_or_measurement_approach":"Assessment of the impact of the epileptic focus on remote brain function (e.g., resting-state functional MRI analyses)."}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Commissariat a l'Energie Atomique et aux Energies Alternatives

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France