2024-517638-16-00招募中1 期
18F-DPA714 PET-MRI study to improve preoperative localisation of the epileptic focus to be resected in drug-resistant partial epilepsy
Commissariat a l'Energie Atomique et aux Energies Alternatives1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
To evaluate the contribution of 18F-DPA-714 PET imaging in locating the seizure zone in patients aged 12 and over with drug-resistant partial epilepsy who are candidates for surgery during their phase 2 work-up.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •FOR PATIENTS: Patients with drug-resistant epilepsy (whose epilepsy epilepsy persists after two types of well-conducted treatment).
- •FOR PATIENTS: Male or female .
- •FOR PATIENTS: Age : ≥ 12 years
- •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
- •FOR HEALTHY VOLUNTEER: Healthy volunteers (i.e. no chronic and/or progressive general pathology)
- •FOR HEALTHY VOLUNTEER: Male or female
- •FOR HEALTHY VOLUNTEER: Age: ≥ 18 years and up to 55 years
- •FOR HEALTHY VOLUNTEER: Social security
排除标准
- •FOR PATIENTS: Any contraindication to MRI.
- •FOR PATIENTS: Pregnant or lactating women, or those not using effective contraception.
- •FOR PATIENTS: Lying position impossible to maintain for long periods.
- •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.
- •FOR PATIENTS: Patients already included in another therapeutic trial using radioactivity.
- •FOR HEALTHY VOLUNTEER: Any contraindication to MRI
- •FOR HEALTHY VOLUNTEER: Women who are pregnant, lactating or not using an effective method of contraception
- •FOR HEALTHY VOLUNTEER: Lying position impossible to maintain for long periods
- •FOR HEALTHY VOLUNTEER: Subject excluded from a medical research protocol.
结局指标
主要结局
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).
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).
次要结局
- Collection and analysis of adverse events and their causal relationship in relation to the entire procedure evaluated.
- Number of subjects who benefited from the entire procedure in accordance with the protocol.
- Number of seizures in patients 1 year after surgery (ILAE classification).
- Study of imaging results in subgroups of patients according to the type epilepsy (temporal or extra-temporal localization, etiology of epilepsy epilepsy, seizure frequency).
- Imaging data in patients not cured by surgery.
- Imaging data in patients rejected after SEEG.
- Topography of PET imaging data 18F-DPA-714 PET vs. MRI data.
- Relationship between epileptic focus and remote brain function.
研究者
Viviane BOUILLERET
Scientific
Commissariat a l'Energie Atomique et aux Energies Alternatives
研究点 (1)
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