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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000209-25 | EudraCT Number |
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Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MRI in pain-free remission period | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients with cluster headache episodic and between 20 and 45 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genevieve Demarquay, MD | Contact | 04 72 35 79 00 | +33 | Genevieve.demarquay@chu-lyon.fr |
| Luc Zimmer, PhD | Contact | 04 72 68 86 09 | luc.zimmer@univ-lyon1.fr |
| Name | Affiliation | Role |
|---|---|---|
| Genevieve Demarquay, MD | Centre d'évaluation et traitement de la douleur | Principal Investigator |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| 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 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |