Exploration of Cluster Headache in a PET-MRI Study

N/AUnknownNCT05084469

Hospices Civils de Lyon12 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cluster Headache, Episodic

Interventions

PET-MRI in pain-free remission periodPROCEDURE

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.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

[18F]F13640 binding

Comparison of 5-HT1A density by measuring non-displaceable binding

Time frame: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans

Secondary Outcomes

[18F]F13640 binding

Comparison of 5-HT1A density by measuring non-displaceable binding

Time frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans

MRI images - fMRI

Comparison of cerebral activity (fMRI)

Time frame: 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans

MRI images - fMRI

Comparison of cerebral activity (fMRI)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Central Contacts

Genevieve Demarquay, MD

CONTACT

04 72 35 79 00 Genevieve.demarquay@chu-lyon.fr

Luc Zimmer, PhD

CONTACT

04 72 68 86 09 luc.zimmer@univ-lyon1.fr

Data from ClinicalTrials.gov

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