Cluster Headache, EpisodicF13640-AVFNCT05084469
Exploration of Cluster Headache in a PET-MRI Study
An observational study of Cluster Headache, Episodic, run by Hospices Civils de Lyon.
Trial summary
Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Cluster Headache, Episodic
- What is being tested?
- PET-MRI in pain-free remission period
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients with cluster headache episodic and between 20 and 45 years old.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Cluster Headache, Episodic
- Being tested
- PET-MRI in pain-free remission period
- Keywords
- Cluster Headache, PET-MRI, 5HT1A
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI in pain-free remission periodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PET-MRI in pain-free remission period |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]F13640 binding
Comparison of 5-HT1A density by measuring non-displaceable binding
Measured: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans
Secondary outcomes (16)
[18F]F13640 binding
Comparison of 5-HT1A density by measuring non-displaceable binding
Measured: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
MRI images - fMRI
Comparison of cerebral activity (fMRI)
Measured: 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans
MRI images - fMRI
Comparison of cerebral activity (fMRI)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster Headache, EpisodicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Genevieve Demarquay, MD, Principal investigator, Centre d'évaluation et traitement de la douleur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084469
- Sponsor's protocol ID
- 69HCL20_1158
- Other IDs
- 2021-000209-25
- Acronym
- F13640-AVF
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the 5-HT1A Receptor in Cluster Headache : a PET-MRI Study Using the PET Radiopharmaceutical [18F]F13640
- ClinicalTrials.gov ID
- NCT05084469
- Acronym / sponsor ID
- F13640-AVF / 69HCL20_1158
- Conditions
- Cluster Headache, Episodic
- Keywords
- Cluster Headache, PET-MRI, 5HT1A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episodic Cluster Headache patients | – | Procedure: PET-MRI in pain-free remission periodPatients 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients with cluster headache episodic and between 20 and 45 years old.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRI in pain-free remission periodPatients 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. | Procedure or surgery | Episodic Cluster Headache patients |
Primary outcome
[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
16 secondary outcomes
[18F]F13640 binding
Time frame: 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
MRI images - fMRI
Time frame: 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
MRI images - perfusion MRI
Time frame: 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
MRI images - BOLD signal
Time frame: 75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans
Change in general anxiety
Time frame: baseline
Change in general anxiety
Time frame: 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
Mood changing (depression)
Time frame: baseline
Mood changing (depression)
Time frame: 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.
Evaluation of pain
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve Demarquay, MD principal investigator
Centre d'évaluation et traitement de la douleur
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, Episodic, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genevieve Demarquay, MD (04 72 35 79 00 ext. +33, Genevieve.demarquay@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]F13640 binding (time frame: 30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.