Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT05084469
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of Cluster Headache in a PET-MRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[18F]F13640 binding', 'timeFrame': '30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans', 'description': 'Comparison of 5-HT1A density by measuring non-displaceable binding'}], 'secondaryOutcomes': [{'measure': '[18F]F13640 binding', 'timeFrame': '75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans', 'description': 'Comparison of 5-HT1A density by measuring non-displaceable binding'}, {'measure': 'MRI images - fMRI', 'timeFrame': '30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans', 'description': 'Comparison of cerebral activity (fMRI)'}, {'measure': 'MRI images - fMRI', 'timeFrame': '75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans', 'description': 'Comparison of cerebral activity (fMRI)'}, {'measure': 'MRI images - perfusion MRI', 'timeFrame': '30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans', 'description': 'Comparison of cerebral blood flow (perfusion MRI).'}, {'measure': 'MRI images - perfusion MRI', 'timeFrame': '75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans', 'description': 'Comparison of cerebral blood flow (perfusion MRI).'}, {'measure': 'MRI images - BOLD signal', 'timeFrame': '30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans', 'description': 'Comparison of functional connectivity (BOLD signal).'}, {'measure': 'MRI images - BOLD signal', 'timeFrame': '75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans', 'description': 'Comparison of functional connectivity (BOLD signal).'}, {'measure': 'Change in general anxiety', 'timeFrame': 'baseline', 'description': '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).'}, {'measure': 'Change in general anxiety', 'timeFrame': 'day of imaging visit at pain-free remission period up to 24 months after inclusion', 'description': '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).'}, {'measure': 'Change in general anxiety', 'timeFrame': 'day of imaging visit during cluster period up to 24 months after inclusion', 'description': '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).'}, {'measure': 'Mood changing (depression)', 'timeFrame': 'baseline', 'description': '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).'}, {'measure': 'Mood changing (depression)', 'timeFrame': 'day of imaging visit at pain-free remission period up to 24 months after inclusion', 'description': '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).'}, {'measure': 'Mood changing (depression)', 'timeFrame': 'day of imaging visit during cluster period up to 24 months after inclusion.', 'description': '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).'}, {'measure': 'Evaluation of pain', 'timeFrame': 'During PET-MRI scans, 30 minutes from t=60 to t=90 after [18F]F13640 injection', 'description': '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)'}, {'measure': 'Evaluation of pain', 'timeFrame': 'During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection', 'description': '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)'}, {'measure': 'Acute anxiety', 'timeFrame': 'At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes', 'description': 'Evaluation of acute anxiety during days of PET-MRI using a VAS questionnaire (0= no anxiety; 10= anxiety as bad as can be)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cluster Headache', 'PET-MRI', '5HT1A'], 'conditions': ['Cluster Headache, Episodic']}, 'descriptionModule': {'briefSummary': 'Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer \\[18F\\]F13640.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients with cluster headache episodic and between 20 and 45 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age between 20 to 45 years old\n* Weight between 50 to 90 kg\n* No psychiatric or neurologic pathological history\n* No cranial trauma history with loss of consciousness\n* No juridical protection\n* Free and informed consent\n* Affiliated with a social security scheme or similar\n\nExclusion Criteria:\n\n* 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\n* Subject already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation\n* Subject with a contraindication to MRI exams\n* Subject with a contraindication to PET scans using \\[18F\\] F13640: hypersensitivity to the active substance or to one of the excipients (sodium chloride)\n* Subject with a contraindication to sumatriptan\n* Patients with an active infectious disease or associated serious and progressive medical pathology\n* Subjects with an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc...) as judged by the investigator\n* Patient having exceeded the annual amount of compensation authorized for participation in research protocols.'}, 'identificationModule': {'nctId': 'NCT05084469', 'acronym': 'F13640-AVF', 'briefTitle': 'Exploration of Cluster Headache in a PET-MRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Exploration of the 5-HT1A Receptor in Cluster Headache : a PET-MRI Study Using the PET Radiopharmaceutical [18F]F13640', 'orgStudyIdInfo': {'id': '69HCL20_1158'}, 'secondaryIdInfos': [{'id': '2021-000209-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Episodic Cluster Headache patients', 'description': '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.', 'interventionNames': ['Procedure: PET-MRI in pain-free remission period']}], 'interventions': [{'name': 'PET-MRI in pain-free remission period', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Episodic Cluster Headache patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Genevieve Demarquay, MD', 'role': 'CONTACT', 'email': 'Genevieve.demarquay@chu-lyon.fr', 'phone': '04 72 35 79 00', 'phoneExt': '+33'}, {'name': 'Luc Zimmer, PhD', 'role': 'CONTACT', 'email': 'luc.zimmer@univ-lyon1.fr', 'phone': '04 72 68 86 09'}], 'overallOfficials': [{'name': 'Genevieve Demarquay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'évaluation et traitement de la douleur"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}