Exploration of the 5-HT1A Receptor in Cluster Headache : a PET-MRI Study Using the PET Radiopharmaceutical [18F]F13640

Hospices Civils de Lyon0 个研究点目标入组 12 人开始时间: 2021年11月1日最近更新: 2021年10月19日

适应症

试验速览

阶段: 不适用
发起方: Hospices Civils de Lyon
入组人数: 12
主要终点: [18F]F13640 binding

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 20 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Age between 20 to 45 years old
•Weight between 50 to 90 kg
•No psychiatric or neurologic pathological history
•No cranial trauma history with loss of consciousness
•No juridical protection
•Free and informed consent
•Affiliated with a social security scheme or similar

排除标准

•Subject with present or past dependence on alcohol or any other addictive substance according to the DSM-IV-TR criteria, with the exception of nicotine, caffeine and cannabis
•Subject already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
•Subject with a contraindication to MRI exams
•Subject with a contraindication to PET scans using [18F] F13640: hypersensitivity to the active substance or to one of the excipients (sodium chloride)
•Subject with a contraindication to sumatriptan
•Patients with an active infectious disease or associated serious and progressive medical pathology
•Subjects with an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc...) as judged by the investigator
•Patient having exceeded the annual amount of compensation authorized for participation in research protocols.

结局指标

主要结局

[18F]F13640 binding

时间窗: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans

Comparison of 5-HT1A density by measuring non-displaceable binding

次要结局

MRI images - BOLD signal(75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans)
Change in general anxiety(day of imaging visit during cluster period up to 24 months after inclusion)
Evaluation of pain(During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection)
Acute anxiety(At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes)
[18F]F13640 binding(75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans)
MRI images - fMRI(75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans)
MRI images - perfusion MRI(75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans)
Mood changing (depression)(day of imaging visit during cluster period up to 24 months after inclusion.)

研究者

发起方

Hospices Civils de Lyon

申办方类型

Other

责任方

Sponsor

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