NCT05084469

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 19, 2021

Status Verified

June 1, 2021

Enrollment Period

2.3 years

First QC Date

June 9, 2021

Last Update Submit

October 18, 2021

Conditions

Cluster Headache, Episodic

Keywords

Cluster HeadachePET-MRI5HT1A

Outcome Measures

Primary Outcomes (1)

  • [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 Outcomes (16)

  • [18F]F13640 binding

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

  • MRI images - fMRI

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

  • MRI images - fMRI

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

  • MRI images - perfusion MRI

    30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans

  • MRI images - perfusion MRI

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

  • +11 more secondary outcomes

Study Arms (1)

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

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.

Episodic Cluster Headache patients

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Genevieve Demarquay, MD

    Centre d'évaluation et traitement de la douleur

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Genevieve Demarquay, MD

CONTACT

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

Luc Zimmer, PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

October 19, 2021

Study Start

November 1, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

October 19, 2021

Record last verified: 2021-06