[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100512389","phase-1-a-phase-1-study-of-99mtc-p514-in-healthy-volunteers-and-patients-with-al-or-attr-systemic-amyloidosis-100512389",false,"NCT05951816","A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis","Phase 1 Study to Investigate the Dosimetry and Biodistribution of a Single Intravenous Administration of 99mTc-p5+14 Using SPECT\u002FCT Imaging and Planar Gamma Scintigraphy in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis","Inclusion Criteria:\n\nPART 1\n\n1\\) Understand the study procedures and agree to participate in the study by giving written informed consent..\n\n2\\) Be male or female \\>18 years of age. 3) Women of child-bearing potential (WOCBP) (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n\n4\\) WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n\n5\\) Be a healthy volunteer (n=3) or have a confirmed diagnosis of systemic amyloidosis (n=2) based on either a histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material with aberrant organ-specific biomarkers indicating amyloid involvement, physical examination, or imaging study.\n\n6\\) Healthy volunteers must also meet inclusion criteria for Part 3. PART 2\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. WOCBP (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Have one of the following:\n\n   1. a confirmed diagnosis of systemic AL amyloidosis, based on either a histologic confirmation of a cardiac or extracardiac biopsy containing deposits of apple-green birefringent, Congophilic material AND imaging parameters (ECHO or CMR) indicative of cardiac involvement.\n   2. a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR or 99mTc-PYP) indicative of cardiac involvement, with no evidence of abnormal serum free light chains.\n6. Have a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.\n\nPART 3\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. WOCBP (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Be in good general health, as determined by no clinically significant findings (including Type 2 diabetes mellitus) in the opinion of the Investigator from review of the medical history.\n6. Does not have a diagnosis of amyloidosis nor has a first- or second-degree relative (parent, sibling, child, aunt, uncle, niece, nephew) with confirmed or suspected familial amyloidosis.\n\nPART 4\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. Women of child-bearing potential (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Has a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR), or abnormal serum biomarkers indicative of cardiac involvement, with no evidence of abnormal serum free light chains.\n6. Has a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.\n7. Has a negative 99mTc-PYP imaging study.\n\nExclusion Criteria:\n\nPARTS 1-4\n\n1. Due to annual dosimetry limitations, patients who have participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the last 6 months.\n2. Is pregnant or breast-feeding.\n3. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.\n4. Receiving hemodialysis or peritoneal dialysis.\n5. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol.\n6. Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.\n7. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to 99mTc-p5+14 administration.\n8. Have previously received any dose of p5+14, in any form.\n9. Have a serum AST \\>2x the upper limit of normal or 80 IU\u002FL AND total bilirubin \\> 1.5x the upper limit of normal or 1.8 mg\u002FdL within the previous six months of enrollment.\n10. Have a serum ALT \\>2x the upper limit of normal or 64 IU\u002FL AND total bilirubin \\> 1.5x the upper limit of normal or 1.8 mg\u002FdL within the previous six months of enrollment.\n11. Have a QTc interval, using Bazett's formula (QTcB) of \\>530 ms, measured within six months prior to enrollment, or assessed prior to injection.",true,"ALL","18 Years",{"count":20,"type":21},31,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.",[27],"Systemic Amyloidosis",[29,30,31,32],"Amyloidosis","p5+14","SPECT imaging","iodine-124-evuzamitide","RECRUITING","2026-07-22",{"date":36,"type":37},"2026-07-24","ACTUAL",{"date":39,"type":37},"2023-09-18",{"date":41,"type":21},"2027-06",{"name":43,"class":44},"University of Tennessee Graduate School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100646517","hungarian-national-systemic-amyloidosis-registry-100646517","NCT07689331","Hungarian National Systemic Amyloidosis Registry","Hungarian National Systemic Amyloidosis Registry (AMYREG) - A Multi-Center, Longitudinal, Observational Survey of Patients With Systemic Amyloidosis","AMYREG","Inclusion Criteria:\n\n* Diagnosis of systemic amyloidosis\n* Patients aged ≥18 years at the time of enrollment\n* Signed informed consent form by the patient\n* Treating physician's consent\n* Availability of accessible medical history\n\nExclusion Criteria:\n\n* Lack of informed consent in the prospective study",{"count":55,"type":21},300,"3 Years","OBSERVATIONAL","This registry is an observational, multicenter, retrospective and prospective, non-pharmacological study designed to collect and analyze data from patients with systemic amyloidosis treated in inpatient and outpatient cardiology, hematology, nephrology, and neurology departments across Hungary. The registry was established in 2025.",[27,60,61,62],"ATTR Amyloidosis","AL Amyloidosis","Amyloid Cardiomyopathy",[64,65,66],"ATTR","AL","systemic amyloidosis","2026-07-07",{"date":69,"type":37},"2026-07-08",{"date":71,"type":37},"2026-03-08",{"date":73,"type":21},"2028-05",{"name":75,"class":44},"Semmelweis University",12,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":45},"100639454","early-detection-of-amyloidosis-in-monoclonal-gammopathy-using-nuclear-medicine-imaging-100639454","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",{"count":86,"type":21},50,[88],"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)",[91,92,93,61,27],"Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Multiple Myeloma",[95,96,97,98,99,100,101,102,103],"MGUS","MGCS","Amyloid PET","PET\u002FMRI","Florbetaben","Early detection","Systemic amyloidosis","Monoclonal gammopathy","AL amyloidosis","NOT_YET_RECRUITING","2026-05-28",{"date":107,"type":37},"2026-06-03",{"date":109,"type":21},"2026-10",{"date":73,"type":21},{"name":112,"class":44},"University of Zurich",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":45},"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":122,"type":21},40,[124],"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.",[27],"2024-12-25",{"date":129,"type":37},"2024-12-30",{"date":131,"type":37},"2024-05-06",{"date":133,"type":21},"2026-12",{"name":135,"class":44},"Jin Lu, MD"]