Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
12 participants
OBSERVATIONAL
2021-11-01
2024-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Episodic Cluster Headache patients
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.
PET-MRI in pain-free remission period
Patients will performed PET-MRI scans. A first 30 minutes acquisition will be performed at time=60min after injection. A second 75 minutes acquisition will be performed at time=150min. Each scans will contain functional dynamic \[18F\]F13640 PET acquisition, anatomical and functional MRI images acquisition and pain evaluation using a score visual analogic scale.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PET-MRI in pain-free remission period
Patients will performed PET-MRI scans. A first 30 minutes acquisition will be performed at time=60min after injection. A second 75 minutes acquisition will be performed at time=150min. Each scans will contain functional dynamic \[18F\]F13640 PET acquisition, anatomical and functional MRI images acquisition and pain evaluation using a score visual analogic scale.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
20 Years
45 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Genevieve Demarquay, MD
Role: PRINCIPAL_INVESTIGATOR
Centre d'évaluation et traitement de la douleur
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000209-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
69HCL20_1158
Identifier Type: -
Identifier Source: org_study_id