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

October 18, 2021 updated by: Hospices Civils de Lyon

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
[18F]F13640 binding
Time Frame: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
[18F]F13640 binding
Time Frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
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
Time Frame: 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans
Comparison of cerebral activity (fMRI)
30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans
MRI images - fMRI
Time Frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
Comparison of cerebral activity (fMRI)
75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
MRI images - perfusion MRI
Time Frame: 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans
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
Time Frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
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
Time Frame: 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans
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
Time Frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
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
Time Frame: baseline
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
Time Frame: day of imaging visit at pain-free remission period up to 24 months after inclusion
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
Time Frame: day of imaging visit during cluster period up to 24 months after inclusion
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)
Time Frame: baseline
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)
Time Frame: day of imaging visit at pain-free remission period up to 24 months after inclusion
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)
Time Frame: day of imaging visit during cluster period up to 24 months after inclusion.
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
Time Frame: During PET-MRI scans, 30 minutes from t=60 to t=90 after [18F]F13640 injection
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
Time Frame: During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection
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
Time Frame: At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Genevieve Demarquay, MD, Centre d'évaluation et traitement de la douleur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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