[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634120":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"FUO\u002FIUO","EXPERIMENTAL",null,[13],"Diagnostic Test: [18F]AlF-FAPI-74 PET\u002FCT",{"label":15,"type":10,"description":11,"interventionNames":16},"IgG4-related disease",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Axial Spondyloarthritis",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DIAGNOSTIC_TEST","[18F]AlF-FAPI-74 PET\u002FCT","A \\[18F\\]AlF-FAPI-74 PET\u002FCT will be performed at the same site of the screening visit (UZ Leuven). The patient will get an IV line, through which the \\[18F\\]AlF-FAPI-74 will be injected in one bolus (3,5 MBq\u002Fkg). After 60 minutes, the acquisition on the PET\u002FCT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. If the patient receives therapy (for IgG4-RD and AxSpA), a second \\[18F\\]AlF-FAPI-74 PET\u002FCT will be performed three months later.",[18,9,15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Lennert Boeckxstaens, MD","CONTACT","+0032 16 34 37 15","lennert.boeckxstaens@uzleuven.be",[33],{"facility":34,"status":35,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University Hospital Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":41,"coordinates":42},"Point",[43,44],4.70093,50.87959,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":48,"phoneExt":11,"email":31},"0032 1634 37 15",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100634120","phase-2-the-investigators-will-evaluate-the-diagnostic-performance-of-18f-alf-fapi-74-petct-in-inflammatory-disorders-and-compare-it-with-the-current-gold-standard-for-inflammation-fdg-petct-in-three-patient-cohort-patients-presenting-with-fever-of-unknown-origin-igg4-rd-and-axspa-100634120",false,"NCT07535554","The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET\u002FCT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET\u002FCT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.","Prospective Diagnostic Performance of PET\u002FCT Using the Novel Fibroblast Imaging Tracer [18F]-AlF-FAPI-74 Versus Standard of Care [18F]-FDG in Inflammatory Disorders","Inclusion Criteria FUO:\n\n* An illness of more than 3 weeks' duration,\n* Temperature exceeding 38.3°C on \\> 3 occasions, or elevated inflammatory markers on \\> 3 occasions\n* Diagnosis uncertain despite appropriate first-line investigations.\n\nInclusion criteria IgG4-RD:\n\n* High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line investigations and blood tests.\n* Patients with a new diagnosis of IgG4-RD on histopathology and need for further assessment of disease extent with PET\u002FCT,\n* Relapse of diagnosed IgG4-RD on histopathology according to an experienced clinician of Internal Medicine\n\nInclusion criteria AxSpA:\n\n* High clinical suspicion of axial spondyloarthropahy according to an experienced rheumatology (based on inflammary back pain \\> 3 months, insidious onset, morning stifness, improvement with exercise and worsening in rest, pain worse at night, age at onset \\\u003C45 years of age, imaging findings).\n* Patient has persisting inflammatory back pain after 2 different types of NSAID's (tried for over 2-4 weeks), and is therefore eligible for biological DMARDS therapy.\n\nExclusion Criteria:\n\n* Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.\n* Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n* Female who is pregnant (urinary hCG test will be performed in every WOCBP), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n* Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n* Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients.\n* Active treatment has already commenced","ALL","18 Years",{"count":61,"type":62},140,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE2","PHASE3","The aim of the study to evaluate the performance of new \\[18F\\]-AlF-FAPI-74 PET\u002FCT in three inflammatory disorders (fever of unknown origin, IgG4-related disease and axial spondyloarthritis) and compare with the current stand-of-care \\[18F\\]-FDG PET\u002FCT",[69,70,71,72],"Fever of Unknown Origin","IgG4 Related Disease","Axial Spondylarthritis (axSpA)","Inflammation of Unknown Origin","2026-04-14",{"date":75,"type":76},"2026-04-17","ACTUAL",{"date":78,"type":76},"2025-09-17",{"date":80,"type":62},"2030-03-31",{"name":5,"class":6},1]