[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541901":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"AzaFol first, FDG second","EXPERIMENTAL","AzaFol PET\u002FCT imaging followed by FDG PET\u002FCT imaging (standard of care)",[13,14],"Drug: AzaFol","Drug: FDG",{"label":16,"type":17,"description":18,"interventionNames":19},"FDG first, AzaFol second","ACTIVE_COMPARATOR","FDG PET\u002FCT imaging (standard of care) imaging followed by AzaFol PET\u002FCT",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AzaFol","AzaFol-PET\u002FCT imaging",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"FDG","FDG-PET\u002FCT imaging",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Britta Maurer","Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+41 31 63 2 7229","RI-Studien@insel.ch",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Rheumatology and Immunology, University Hospital Bern, Inselspital","RECRUITING","Bern","3010","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.44744,46.94809,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":40},"Britta Maurer, Prof. Dr. med.","+41 31 63 2 72 29",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":6},"Paul Scherrer Institut, Center for Proton Therapy","100541901","phase-2-a-clinical-trial-to-investigate-18f-azafol-in-the-diagnosis-of-large-vessel-vasculitis-100541901",false,"NCT06335888","A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis","Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis","CRAFT","Inclusion Criteria:\n\n* Individuals ≥ 50 years with clinical suspicion of GCA\n* Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit\n* Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)\u002Finstitutional review board (IRB), prior to the initiation of any screening or study-specific procedures.\n* Are willing and able to comply with procedures required in this protocol.\n\nExclusion Criteria:\n\n1. Folate deficiency\n2. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug\n3. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed)\n4. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\\[18F\\]FDG tracer application\n5. Glucose level \\> 10 mmol\u002Fl at the timepoint of 2-\\[18F\\]FDG PET\u002FCT\n6. Unable to remain in the PET\u002FCT for the duration of the examination\n7. Unable to lie still for the duration of the examination (45 min)\n8. Unable not to eat or drink (except water) for 6 hours prior to 2-\\[18F\\]FDG tracer application\n9. Prior PET-imaging within 60 days before baseline\n10. Intake of vitamin supplements containing \\> 1mg\u002Fday folic acid within 48 h prior to the PET\u002FCT with AzaFol\n11. Known hypersensitivity or allergy to folic acid\n12. Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons\n13. Participation in another study with investigational drug within the 7 days preceding and during the present study.","ALL","50 Years",{"count":75,"type":76},70,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET\u002FCT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\\[18F\\]FDG-PET\u002FCT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.\n\nParticipants will undergo AzaFol-PET\u002FCT imaging at a single timepoint.",[82],"Giant Cell Arteritis",[84,85],"Tracer","PET imaging","2026-04-30",{"date":88,"type":89},"2026-05-01","ACTUAL",{"date":91,"type":89},"2025-02-03",{"date":93,"type":76},"2029-05",{"name":5,"class":6},1]