Exploration of Cluster Headache in a PET-MRI Study (F13640-AVF)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cluster Headache, Episodic
• Intervention / Treatment: Procedure: PET-MRI in pain-free remission period

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

• Study Contact: Name: Genevieve Demarquay, MD; Phone Number: +33 04 72 35 79 00; Email: Genevieve.demarquay@chu-lyon.fr
• Study Contact Backup: Name: Luc Zimmer, PhD; Phone Number: 04 72 68 86 09; Email: luc.zimmer@univ-lyon1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Male patients with cluster headache episodic and between 20 and 45 years old.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Genevieve Demarquay, MD, Centre d'évaluation et traitement de la douleur

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): February 1, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (ACTUAL): October 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Cluster Headache; PET-MRI; 5HT1A
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: 69HCL20_1158; 2021-000209-25 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No