Exploration of Cluster Headache in a PET-MRI Study (NCT05084469) | Clinical Trial Compass
UnknownNot Applicable
Exploration of Cluster Headache in a PET-MRI Study
12 participantsStarted 2021-11-01
Plain-language summary
Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer \[18F\]F13640.
Who can participate
Age range20 Years – 45 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male
* 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
Exclusion Criteria:
* 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.
What they're measuring
1
[18F]F13640 binding
Timeframe: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans