To study the potential of P-glycoprotein-mediated efflux transport of [11C]metoclopramide as a biomarker of drug-resistance in epilepsy

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

•Age: =18 years old
•Ability to comprehend the full nature and purpose of the study, including possible risks.
•Diagnosis:
oGroup 1: drug resistant nonlesional focal epilepsy; suspected epileptogenic area will be delineated based on the results of phase 1 presurgical evaluation
oGroup 2: drug resistant epilepsy patients with epileptogenic structural lesion (except seizures associated to tumors such as glioma II); suspected epileptogenic area will be delineated based on the results of phase 1 presurgical evaluation
oGroup 3: Patients with focal epilepsy, who are seizure free for at least 1 year
oGroup 4: Patients with multiregional seizure onset zones (lesional and nonlesional subjects may be included)
oGroup 5: Healthy volunteers (serve as controls)
•Physical examination and laboratory analysis: 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

Exclusion Criteria

•Age:<18 years old
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials