Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-04-05 @ 7:49 PM
Study NCT ID:
NCT03353103
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'carotid F18-NaF uptake', 'timeFrame': 'baseline', 'description': 'do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination'}], 'secondaryOutcomes': [{'measure': 'comparaison of F18-NaF PET and Carotid MRI', 'timeFrame': 'baseline', 'description': 'comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination'}, {'measure': 'F18-NaF PET uptake', 'timeFrame': 'baseline', 'description': 'comparaison between F18-NaF uptake at pre-operative imaging'}, {'measure': 'histology', 'timeFrame': 'baseline', 'description': 'comparaison between histology at post-operative histologic analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Health care system affiliation\n* Referred to carotid endarterectomy\n* Symptomatic patients:\n\n * Carotid stenosis between 70 and 99% (NASCET criteria)\n * TIA or minor stroke attack (RANKIN ≤ 3)\n* Asymptomatic patients:\n\n * Carotid stenosis between 70 and 99% (NASCET criteria)\n * No symptoms\n* Patient who has been informed of the study and has given his/her informed consent\n\nExclusion Criteria:\n\n* Contra indication to MRI\n* Renal failure (clearance \\< 30ml/mn)\n* Patient with active inflammatory disease\n* History of cancer\n* Pregnancy or lactation\n* Patient with carotid disease treated by fibrinolysis\n* Patient under guardianship, or unable to understand the purpose of the study'}, 'identificationModule': {'nctId': 'NCT03353103', 'acronym': 'CAROTEP', 'briefTitle': 'Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study', 'orgStudyIdInfo': {'id': '17-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'symptomatic', 'interventionNames': ['Drug: Sodium fluoride F-18 PET imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'asymptomatic', 'interventionNames': ['Drug: Sodium fluoride F-18 PET imaging']}], 'interventions': [{'name': 'Sodium fluoride F-18 PET imaging', 'type': 'DRUG', 'description': 'prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging', 'armGroupLabels': ['asymptomatic', 'symptomatic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucie Camelière', 'role': 'CONTACT', 'email': 'cameliere-l@chu-caen.fr', 'phone': '+33231065161'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Lucie Cameliere, MD', 'role': 'CONTACT', 'email': 'cameliere-l@chu-caen.fr', 'phone': '+33231065161'}, {'name': 'Alain Manrique, MD PhD', 'role': 'CONTACT', 'email': 'manrique@cyceron.fr', 'phone': '+33231470287'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}