Clinical trial NCT05084469: Exploration of Cluster Headache in a PET-MRI Study
Official title: Exploration of the 5-HT1A Receptor in Cluster Headache : a PET-MRI Study Using the PET Radiopharmaceutical [18F]F13640
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cluster Headache, Episodic
Keywords: Cluster Headache
PET-MRI
5HT1A
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with cluster headache episodic and between 20 and 45 years old.

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


Eligibility criteria: 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.

Primary outcomes:
measure: [18F]F13640 binding
timeFrame: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans
Secondary outcomes:
measure: [18F]F13640 binding
timeFrame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
measure: MRI images - fMRI
timeFrame: 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans
measure: MRI images - fMRI
timeFrame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
measure: MRI images - perfusion MRI
timeFrame: 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans
measure: MRI images - perfusion MRI
timeFrame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
measure: MRI images - BOLD signal
timeFrame: 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans
measure: MRI images - BOLD signal
timeFrame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
measure: Change in general anxiety
timeFrame: baseline
measure: Change in general anxiety
timeFrame: day of imaging visit at pain-free remission period up to 24 months after inclusion
measure: Change in general anxiety
timeFrame: day of imaging visit during cluster period up to 24 months after inclusion
measure: Mood changing (depression)
timeFrame: baseline
measure: Mood changing (depression)
timeFrame: day of imaging visit at pain-free remission period up to 24 months after inclusion
measure: Mood changing (depression)
timeFrame: day of imaging visit during cluster period up to 24 months after inclusion.
measure: Evaluation of pain
timeFrame: During PET-MRI scans, 30 minutes from t=60 to t=90 after [18F]F13640 injection
measure: Evaluation of pain
timeFrame: During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection
measure: Acute anxiety
timeFrame: At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Centre d'évaluation et traitement de la douleur
name: Genevieve Demarquay, MD
role: PRINCIPAL_INVESTIGATOR
References: