[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-amyloidosis":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"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":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27,28,29,30,31],"Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Multiple Myeloma","AL Amyloidosis","Systemic Amyloidosis",[33,34,35,36,37,38,39,40,41],"MGUS","MGCS","Amyloid PET","PET\u002FMRI","Florbetaben","Early detection","Systemic amyloidosis","Monoclonal gammopathy","AL amyloidosis","NOT_YET_RECRUITING","2026-05-28",{"date":45,"type":46},"2026-06-03","ACTUAL",{"date":48,"type":21},"2026-10",{"date":50,"type":21},"2028-05",{"name":52,"class":53},"University of Zurich","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":54},"100542407","phase-2-bortezomib-pomalidomide-dexamethasone-for-systemic-al-amyloidosis-100542407","NCT06342466","Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis","A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis","Inclusion Criteria:\n\n1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.\n2. Newly diagnosed or previous treated AL amyloidosis\n3. Patients must be ≥ 18 years of age.\n4. ECOG performance status 0, 1 or 2.\n5. Measurable disease defined by at least one of the following:\n\n   ① serum free light chain (FLC) ≥2.0 mg\u002FdL (20 mg\u002FL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg\u002FdL (20 mg\u002FL).\n\n   ②. presence of a monoclonal spike that is ≥5 g\u002Fl.\n6. Symptomatic organ involvement (heart, kidney, liver\u002FGI tract, peripheral nervous system).\n7. Absolute neutrophil count (ANC) ≥1.0 X 10\\^9\u002FL, Hemoglobin ≥70 g\u002FL, Platelets ≥50 X 10\\^9\u002FL\n8. eGFR ≥20 mL\u002Fmin\u002F 1.73 m\\^2\n9. Written informed consent in accordance with local and institutional guidelines.\n10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","90 Years",{"count":64,"type":21},40,[66],"PHASE2","This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.",[31],"RECRUITING","2024-12-25",{"date":72,"type":46},"2024-12-30",{"date":74,"type":46},"2024-05-06",{"date":76,"type":21},"2026-12",{"name":78,"class":53},"Jin Lu, MD"]