EUCTR2020-005954-78-FR招募中1 期
Exploring P-glycoprotein-mediated efflux transport at the blood-brain barrier as a biomarker of drug-resistance in focal epilepsy - EPIFLUX
CEA0 个研究点目标入组 100 人开始时间: 2021年4月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Age: =18 years old<65
- •Ability to comprehend the full nature and purpose of the study, including possible risks.
- •Diagnosis:
- •oGroup 1: patients with drug-resistant epilepsy without structural lesions the suspected epileptogenic outbreak will be delineated based on the results of phase 1 of the pre-surgical work-up.
- •oGroup 2: patients with epileptogenic structural lesionals and drugresistant epilepsy with the exception of patients whose epilepsy is linked to the presence of a tumor such as a grade 2 glioma); the suspected epileptogenic focus will be delineated based on the results of the phase 1 pre-surgical workup.
- •oGroup 3: patients with medically controlled focal epilepsy not having had a crisis for at least 1 year.
- •oGroup 4: Patients with multifocal epilepsy, which may or may not include subjects with lesional epilepsy.
- •oGroup 5: Patients with idiopathic generalized epilepsy phamacoresistant well-characterised on EEG
- •oGroup 6: Healthy volunteers
- •Physical examination and laboratory analysis (standard biochemistry, blood count, coagulation test): no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study
- •No additional neurological or other diseases, which the investigator considers may affect the outcome of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Unwillingness to sign the informed consent
- •Any abnormality found as part of the pre-treatment screening or in any of the performed laboratory tests that the investigator considers to interfere with the objectives of the study
- •Intake of medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study. Furthermore, intake of any drugs which may cause potential harm to the subject (e.g. anticoagulation for subjects undergoing arterial cannulation) is forbidden.
- •Changes in medication within 2 weeks before the scan, which the investigator considers may affect the validity of the study
- •Any disease or condition (e.g. pregnancy, breastfeeding, evolutive tumor) which the investigator considers may affect the subject’s safety or outcome of the study
- •Exposure to radiation exceeding the allowed maximum foreseen by the current guidelines
- •History of ethanol dependence and currently abstinent
- •Inability to comprehend the full nature and purpose of the study
- •Contraindication for PET or MR imaging e.g. claustrophobia, metallic endoprosthesis, non-MR safe implants
- •Subject participating in a parallel drug study/ radiotraceur <1year
- •Vulnerable person (person under guardianship, curatorship)
研究者
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