Exploration of Cluster Headache in a PET-MRI Study

Cluster Headache, Episodic Clinical Trial

— F13640-AVF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05084469
• Other study ID #: 69HCL20_1158
• Secondary ID: 2021-000209-25
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: Genevieve Demarquay, MD
• Phone: 04 72 35 79 00
• Email: Genevieve.demarquay[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Cluster Headache, Episodic
• Headache

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	[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
Secondary	MRI images - fMRI	Comparison of cerebral activity (fMRI)	30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans
Secondary	MRI images - fMRI	Comparison of cerebral activity (fMRI)	75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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