[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639454":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":38,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":38,"enrollmentInfo":73,"targetDuration":38,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":94,"whyStopped":38,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,13,17],{"label":9,"type":6,"description":10,"interventionNames":11},"Monoclonal Gammopathy, Amyloid-Negative","Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls)",[12],"Drug: ¹⁸F-florbetaben",{"label":14,"type":6,"description":15,"interventionNames":16},"Monoclonal Gammopathy, Amyloid-Positive","Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort)",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"AL Amyloidosis","Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy)",[12],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","¹⁸F-florbetaben","Single intravenous dose of \\~300 MBq ¹⁸F-florbetaben followed by PET\u002FMR (or PET\u002FCT, if MRI is contraindicated), from the skull base to below the kidneys",[18,9,14],[28,29],"Neuraceq","Florbetaben",[31],{"name":32,"affiliation":5,"role":33},"Dominik C Benz, PD Dr. med.","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+41432531191",null,"dominik.benz@usz.ch",{"name":41,"role":36,"phone":38,"phoneExt":38,"email":42},"Mirjam Marty","mirjam.marty@usz.ch",[44],{"facility":45,"status":38,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital Zurich","Zurich","Canton of Zurich","8091","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],8.55,47.36667,{"lat":55,"lon":54},[58,59,60],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},{"name":41,"role":36,"phone":38,"phoneExt":38,"email":42},{"name":32,"role":33,"phone":38,"phoneExt":38,"email":38},{"type":62,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100639454","early-detection-of-amyloidosis-in-monoclonal-gammopathy-using-nuclear-medicine-imaging-100639454",false,"NCT07624760","Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging","Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET\u002FMR: a Prospective, Single-Center, Observational Study","MGUS-PET","Inclusion Criteria:\n\n* Participation in the COSMO-AL study\n* Available biopsy test result\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women","ALL","18 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET\u002FMR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy. The main question it aims to answer is: Can ¹⁸F-florbetaben PET\u002FMR identify systemic amyloid deposits across clinically and histologically defined patient groups?\n\nParticipants will:\n\n* Be screened for eligibility and asked to sign an informed consent form\n* Have their vital signs measured\n* Receive a single intravenous injection of approximately 300 MBq ¹⁸F-florbetaben (Neuraceq®), followed by whole-body PET\u002FMR imaging from skull base to below the kidneys. If MRI is contraindicated (e.g., pacemaker, severe claustrophobia), PET\u002FCT will be performed instead. The scan takes approximately one hour, during which participants lie still in the scanner\n* Be monitored during and after the scan for any side effects or adverse events\n* Complete study participation at the end of the imaging session (single visit, no follow-up required)",[81,82,83,18,84],"Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Multiple Myeloma","Systemic Amyloidosis",[86,87,88,89,29,90,91,92,93],"MGUS","MGCS","Amyloid PET","PET\u002FMRI","Early detection","Systemic amyloidosis","Monoclonal gammopathy","AL amyloidosis","NOT_YET_RECRUITING","2026-05-28",{"date":97,"type":98},"2026-06-03","ACTUAL",{"date":100,"type":75},"2026-10",{"date":102,"type":75},"2028-05",{"name":5,"class":6},1]