Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT06558357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-20
First Post:
2024-08-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012213', 'term': 'Rheumatic Fever'}, {'id': 'D011111', 'term': 'Polymyalgia Rheumatica'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of 18-FDG PET scores for diagnostic of Polymyalgia rheumatica.', 'timeFrame': 'up to 9 months', 'description': 'Evaluation of the metabolism of mains joints compared to liver. Calculation of different scores described in literature.'}], 'secondaryOutcomes': [{'measure': 'Analysis of SUV and visual fixation of mains joints.', 'timeFrame': 'up to 9 months', 'description': 'Measure of SUV of mains joints and evaluation of the fixation compared to liver.'}, {'measure': 'Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism.', 'timeFrame': 'up to 9 months', 'description': 'Evaluation of the precedent scores for diagnosis of others rheumatisms. Creation of others scores if some joints seem to be interesting.'}, {'measure': 'Comparaison of scores with clinical, biological and radiological data.', 'timeFrame': 'up to 9 months', 'description': 'Search for correlation between scores and symptoms, blood test or CT/MRI exams.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polymyalgia rheumatica', 'FDG', 'PET', 'Diagnostic performance', 'score'], 'conditions': ['Inflammatory Rheumatism', '18-FDG', 'Positron-emission Tomography']}, 'descriptionModule': {'briefSummary': 'Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.', 'detailedDescription': 'Polymyalgia Rheumatica is difficult to diagnostic because symptoms are non specific and many diseases can be differential diagnosis (cancer, infections, others rheumatisms...).\n\nPET-CT is more often used to help for diagnostic of inflammatory disease, and particularly inflammatory rheumatism.\n\nSome scores have been described to harmonize the diagnosis of Polymyalgia rheumatica.\n\nThe aim of this study is to evaluate the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and compared with others inflammatories diseases such as ankylosing spondylarthritis.\n\nThis is a multicentric retrospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult with inflammatory rheumatism confirmed by specialist, with or without treatment and having a 18-FDG-PET CT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having 18-FDG PET-CT between 2012 and 2024\n* Diagnosis of inflammatory rheumatism by specialist doctor\n* Adult without opposition to use there data for research\n* Affiliate to social security system\n\nExclusion Criteria:\n\n* Refusal participation\n* Patient under juridic protection'}, 'identificationModule': {'nctId': 'NCT06558357', 'acronym': 'RHUMATEP', 'briefTitle': 'Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Evaluation of the Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica and Comparison With Others Inflammatory Rheumatic Diseases.', 'orgStudyIdInfo': {'id': '29BRC24.0172 - RHUMATEP'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Solène QUERELLOU', 'role': 'CONTACT', 'email': 'solene.querellou@chu-brest.fr', 'phone': '0298223080', 'phoneExt': '+33'}, {'name': 'Chloé QUERE', 'role': 'CONTACT', 'email': 'chloe.quere@chu-brest.fr'}], 'overallOfficials': [{'name': 'Solène QUERELLOU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Brest'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}