Exploration of Cluster Headache in a PET-MRI Study

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

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

Conditions
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Cluster Headache, Episodic

Intervention / Treatment
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* Procedure: PET-MRI in pain-free remission period


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Episodic Cluster Headache patients<br>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. | Procedure: PET-MRI in pain-free remission period<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [18F]F13640 binding | Comparison of 5-HT1A density by measuring non-displaceable binding | 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [18F]F13640 binding | Comparison of 5-HT1A density by measuring non-displaceable binding | 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans | 
| MRI images - fMRI | Comparison of cerebral activity (fMRI) | 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans | 
| MRI images - fMRI | Comparison of cerebral activity (fMRI) | 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans | 
| MRI images - perfusion MRI | Comparison of cerebral blood flow (perfusion MRI). | 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans | 
| MRI images - perfusion MRI | Comparison of cerebral blood flow (perfusion MRI). | 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans | 
| MRI images - BOLD signal | Comparison of functional connectivity (BOLD signal). | 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans | 
| MRI images - BOLD signal | Comparison of functional connectivity (BOLD signal). | 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans | 
| Change in general anxiety | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | baseline | 
| Change in general anxiety | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | day of imaging visit at pain-free remission period up to 24 months after inclusion | 
| Change in general anxiety | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | day of imaging visit during cluster period up to 24 months after inclusion | 
| Mood changing (depression) | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | baseline | 
| Mood changing (depression) | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | day of imaging visit at pain-free remission period up to 24 months after inclusion | 
| Mood changing (depression) | Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case). | day of imaging visit during cluster period up to 24 months after inclusion. | 
| Evaluation of pain | Evaluation of pain during days of PET-MRI using a VAS projected on a screen in the camera (0= no pain; 10= pain as bad as can be) | During PET-MRI scans, 30 minutes from t=60 to t=90 after [18F]F13640 injection | 
| Evaluation of pain | Evaluation of pain during days of PET-MRI using a VAS projected on a screen in the camera (0= no pain; 10= pain as bad as can be) | During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection | 
| Acute anxiety | Evaluation of acute anxiety during days of PET-MRI using a VAS questionnaire (0= no anxiety; 10= anxiety as bad as can be) | At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Headache, PET-MRI, 5HT1A