[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613695":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Edinburgh","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"LV-GCA group",null,"Patients with a diagnosis of active, large vessel GCA",[13],"Diagnostic Test: Zirconium Zr 89 labelled rituximab",{"label":15,"type":10,"description":16,"interventionNames":17},"AA control group","Patients with a diagnosis of atherosclerotic aortic aneurysm",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"BCMID control group","Patients with a diagnosis of a B-cell mediated inflammatory disorder",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Zirconium Zr 89 labelled rituximab","All participants will receive a PET scan with zirconium Zr-89 labelled rituximab. Those in the LV-GCA group will receive a follow-up scan after a period of treatment.",[15,19,9],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Neeraj Dhaun, MBChB PhD","CONTACT","+441312426777","bean.dhaun@ed.ac.uk",[35],{"facility":5,"status":10,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Edinburgh","City Of Edinburgh","EH16 4TJ","United Kingdom","UK",{"type":42,"coordinates":43},"Point",[44,45],-3.19648,55.95206,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":32,"phoneExt":10,"email":50},"Dan Pugh, MBChB PhD","dpugh2@ed.ac.uk",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100613695","mapping-b-cell-biology-across-the-cardiovascular-territories-of-giant-cell-arteritis-towards-a-new-therapeutic-approach-rituximap-gca-100613695",false,"NCT07269938","Mapping B-cell Biology Across the Cardiovascular Territories of Giant Cell Arteritis: Towards a New Therapeutic Approach (RituxiMAP GCA)","RituxiMAP GCA","Inclusion Criteria:\n\n* For GCA group:\n\n  1. Adults ≥ 50 years at the time of enrolment\n  2. Meets 2022 American College of Rheumatology\u002FEULAR classification criteria for giant cell arteritis\n  3. Imaging evidence of active LV-GCA in the previous 4 weeks\n  4. Will be managed with corticosteroid monotherapy by the standard care team.\n\nFor BCMID group:\n\n1. Adults ≥ 18 years at the time of enrolment\n2. Meets criteria for a diagnosis of a B-cell mediated immune disorder\n3. Considered to have active disease by referring team\n4. Will be managed as per standard of care by referring team\n\nFor AA group:\n\n1. Adults ≥ 50 years at the time of enrolment\n2. Imaging evidence of atherosclerotic aortic aneurysm\n\nExclusion Criteria:\n\n1. Participants receiving corticosteroids for \\>4 weeks immediately prior to baseline\n2. Previous diagnosis of GCA\n3. History of any major morbidity which the clinical investigator considers contraindicated to study entry\n4. Pregnancy or breastfeeding\n5. Advanced renal dysfunction (eGFR \\\u003C15ml\u002Fmin\u002F1.73m2)\n6. Patients without mental capacity or willingness to provide informed consent\n7. Inability or unwillingness to comply with the radiation protection advice",true,"ALL","50 Years",{"count":64,"type":65},30,"ESTIMATED","OBSERVATIONAL","B cells are a component of the immune system which appear be important in causing all forms of cardiovascular disease. Until now, it has not been possible to directly study these cells in living patients (essential to assess their potential as the target of new treatments). For the first time in any cardiovascular disease, this study will apply cutting edge scanning technology to visualise B cells in the blood vessels of giant cell arteritis (GCA) patients. GCA is a common and potentially deadly disorder of the blood vessels which is caused by abnormalities of the immune system. Current treatments are mainly limited to steroids. Unfortunately, these drugs bring tremendous side effects and so there is an urgent requirement to discover alternatives.\n\nLaboratory investigations tell us that B cells are highly present in GCA and so if the proposed scanning technology fails to identify these cells in the blood vessels of participants, then the technology is unlikely to be useful for other cardiovascular diseases. If, however, the study does successfully visualise B cells, this knowledge could pave the way for clinical trials of B cell targeted treatments (already established in other conditions) as steroid alternatives in GCA.\n\nThis study aims to map the distribution of the radiotracer zirconium-89 labelled rituximab within the blood vessels of patients with newly diagnosed GCA and compare this with two separate control groups without the condition. This will allow us to determine the role of B cells within this condition, and whether patients would benefit from B cell-depleting treatments such as rituximab.",[69],"Giant Cell Arteritis (GCA)",[71,72,73,74],"Giant cell arteritis","Vasculitis","Rituximab","PET scanning","NOT_YET_RECRUITING","2026-06-12",{"date":78,"type":79},"2026-06-16","ACTUAL",{"date":81,"type":65},"2026-10",{"date":83,"type":65},"2029-06",{"name":5,"class":6},1]