Exploration of Cluster Headache in a PET-MRI Study (F13640-AVF)

Civil Hospices of Lyon

Status: Unknown

Conditions: Cluster Headache, Episodic

Treatments: Procedure: PET-MRI in pain-free remission period

Study type: Observational

Funder types: Other

Identifiers

NCT05084469

2021-000209-25 (EudraCT Number)

69HCL20_1158

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Episodic Cluster Headache patients

Description:

Patients will perform two PET-MRI scans: (1) during cluster period and (2) during pain-free remission period. Scans during cluster periods will aim to acquire data before, during and after crisis. Sumatriptan 6mg will be injected subcutaneously under PET-MRI camera to relieve patient pain.

Treatment:

Procedure: PET-MRI in pain-free remission period