[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657291":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":61,"overallOfficials":33,"centralContacts":80,"locations":90,"responsibleParty":106,"collaborators":33,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":33,"enrollmentInfo":119,"targetDuration":33,"studyType":122,"phases":123,"briefSummary":126,"conditions":127,"keywords":33,"overallStatus":130,"whyStopped":33,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety and tolerability evaluation (Part 1)","The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.","Within 30 days following PET imaging",{"measure":14,"description":15,"timeFrame":16},"Focal or diffuse myocardial lesions of ATTR-CA identified with [18F]FIDT-10b PET imaging (Part 2)","The reference standard comprised biopsy-proven extracardiac amyloidosis or pathogenic TTR mutation on genetic testing, in both cases accompanied by typical cardiac imaging appearance; a positive endomyocardial biopsy also served as an independent reference standard.","Through study completion, an average of 3 months",[18,21,24,27,30],{"measure":19,"description":20,"timeFrame":16},"Radiation Dosimetry of [18F]FIDT-10b","OLINDA\u002FEXM will be used to determine the absorbed dose and effective dose per individuals.",{"measure":22,"description":23,"timeFrame":16},"Biodistribution of [18F]FIDT-10b","At different time points after drug injection, perform PET\u002FCT whole-body scans to obtain radioactivity counts in major irradiated organs at each phase, reflecting the drug's biodistribution in the body.",{"measure":25,"description":26,"timeFrame":16},"Identify the ideal time point for imaging after [18F]FIDT-10b injection","Left ventricular myocardial lesion to-blood pool background ratios as a function of time will be measured. The time point resulting in optimal lesion-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.",{"measure":28,"description":29,"timeFrame":16},"Diagnostic performance of [18F]FIDT-10b for ATTR-CA","Assessment of the sensitivity and specificity of PET imaging with \\[18F\\]FIDT-10b for the diagnosis of ATTR-CA based on visual and semi-quantitative scan interpretation.",{"measure":31,"description":32,"timeFrame":16},"Preliminary assessment of lesion targeting by [18F]FIDT-10b as compared to 99mTc-PYP","Detection rate of visual interpretation will be performed to compare the number of detected lesions using both tracers.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NON_RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","Light chain cardiac amyloidosis (AL-CA) and transthyretin cardiac amyloidosis (ATTR-CA) are the two leading causes of cardiac amyloidosis with tremendous impact on patients. Regardless of the underlying cause, the clinical course of cardiac amyloidosis ultimately culminates in impaired cardiac function resulting from amyloid deposition, manifesting as infiltrative cardiomyopathy, conduction abnormalities, and cardiac sympathetic and parasympathetic denervation. These cardiac functional impairments are irreversible. Therefore, early etiological diagnosis and effective therapeutic intervention prior to the progress of severe cardiac dysfunction are importance.\n\nThere is an urgent need for non-invasive, sensitive, accurate, and visualizable approaches for the diagnosis and subtyping of cardiac amyloidosis. Current guidelines recommend bone scintigraphy for the non-invasive diagnosis of ATTR-CA, with a diagnostic specificity exceeding 90% but a sensitivity of only approximately 71%, raising the possibility of missed diagnosis or delayed diagnosis in a subset of patients. This has further propelled the development of PET molecular probes that specifically target amyloid proteins.\n\nThe investigators have preclinical data demonstrating that \\[18F\\]FIDT-10b selectively binds to ATTR deposits with high affinity in vitro via a combination of intermolecular forces, including van fer Waals forces, hydrophobic- hydrophobic interactions, π-π stacking, and hydrogen bonds, with the β-sheet architecture, supporting its potential utility for specific imaging of affected myocardium in patients with ATTR-CA. The investigators propose that this agent has significant potential for clinical translation. This first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution in patients with cardiac amyloidosis and healthy participants (Part 1), and diagnostic performance of \\[18F\\]FIDT-10b in individuals with suspected or confirmed ATTR-CA (Part 2). This study will provide critical insights into the performance of \\[18F\\]FIDT-10b PET imaging as a potential non-invasive imaging tool for the detection of ATTR-CA and compared with routine clinical 99mTc-PYP SPECT imaging.",[42,48,53,57],{"label":43,"type":44,"description":45,"interventionNames":46},"Part 1-Dosimetry and Proof of Concept Study-Cohort A","EXPERIMENTAL","Healthy participants receive \\[18F\\]FIDT-10b for PET imaging.",[47],"Drug: [18F]FIDT-10b",{"label":49,"type":44,"description":50,"interventionNames":51},"Part 1-Dosimetry and Proof of Concept Study-Cohort B","ATTR-CA participants receive \\[18F\\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.",[47,52],"Drug: 99mTc-PYP",{"label":54,"type":44,"description":55,"interventionNames":56},"Part 1-Dosimetry and Proof of Concept Study-Cohort C","AL-CA participants receive \\[18F\\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.",[47],{"label":58,"type":44,"description":59,"interventionNames":60},"Part 2-Diagnostic Performance Study","Suspected or confirmed ATTR-CA participants receive \\[18F\\]FIDT-10b for PET imaging to explore the potential diagnostic performance and additional value of 99mTc-PYP scintigraphy.",[47,52],[62,67,70,72,76,78],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":33},"DRUG","[18F]FIDT-10b","An I.V. bolus injection of up to 10 millicurie (mCi) \\[18F\\]FIDT-10b will be administered, followed by a PET\u002FCT scan.",[43],{"type":63,"name":64,"description":68,"armGroupLabels":69,"otherNames":33},"An I.V. bolus injection of up to 10 millicurie (mCi) \\[18F\\]FIDT-10b will be administered, followed by a PET\u002FCT or PET\u002FMRI scan.",[49],{"type":63,"name":64,"description":65,"armGroupLabels":71,"otherNames":33},[54],{"type":63,"name":73,"description":74,"armGroupLabels":75,"otherNames":33},"99mTc-PYP","An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT\u002FCT scan.",[49],{"type":63,"name":64,"description":68,"armGroupLabels":77,"otherNames":33},[58],{"type":63,"name":73,"description":74,"armGroupLabels":79,"otherNames":33},[58],[81,86],{"name":82,"role":83,"phone":84,"phoneExt":33,"email":85},"Li Huo","CONTACT","+86 18612672038","huoli@pumch.cn",{"name":87,"role":83,"phone":88,"phoneExt":33,"email":89},"Xuezhu Wang","+86 19801117760","xuezhu1226@163.com",[91],{"facility":5,"status":33,"city":92,"state":33,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Beijing","100730","China","CN",{"type":97,"coordinates":98},"Point",[99,100],116.39723,39.9075,{"lat":100,"lon":99},[103],{"name":5,"role":83,"phone":104,"phoneExt":33,"email":105},"+86 69156874","pumchkyc@126.com",{"type":107,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100657291","phase-1-18ffidt-10b-pet-imaging-in-cardiac-amyloidosis-100657291",false,"NCT07835880","[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis","Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis","FIDTCA","Inclusion Criteria:\n\nFor part 1 and 2:\n\nmust have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements\n\nOnly for part 1:\n\nFor ATTR-CA participants:\n\n1. males or females: age 18-90 years\n2. with a confirmed diagnosis of ATTR-CA by standard criteria\n\nFor AL-CA participants:\n\n1. males or females: age 18-80 years\n2. with a confirmed diagnosis of AL-CA by standard criteria\n\nFor healthy participants:\n\n1. males or females: age 18-80 years\n2. no cardiac-related diseases\n\nOnly for part 2:\n\n1. males or females: age 18-90 years\n2. suspected or confirmed ATTR-CA\n\nExclusion Criteria:\n\nFor part 1 and 2:\n\n1. pregnancy or breastfeeding\n2. severe claustrophobia\n3. inability or refusal of consent\n4. any condition deemed by the investigator to interfere with study results or increase participant risk\n\nOnly for part 1:\n\nFor ATTR-CA participants:\n\n1. non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy\n2. diagnosis of primary or secondary AL-CA\n3. contraindications for MRI (eGFR\\\u003C30ml\u002Fmin\u002F1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)\n\nFor AL-CA participants:\n\nco-diagnosis of multiple myeloma, Waldenström macroglobulinemia, or other lymphoproliferative disorders\n\nFor healthy participants:\n\nany cardiac-related diseases based on medical history and corresponding clinical evaluations, including electrocardiography, echocardiography, and laboratory tests\n\nOnly for part 2:\n\n1. non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy\n2. contraindications for MRI (eGFR\\\u003C30ml\u002Fmin\u002F1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)",true,"ALL","18 Years",{"count":120,"type":121},48,"ESTIMATED","INTERVENTIONAL",[124,125],"PHASE1","PHASE2","This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of \\[18F\\]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. This agent has the potential to specifically identify the involved myocardium of patients with transthyretin cardiac amyloidosis (ATTR-CA).",[128,129],"Transthyretin Cardiac Amyloidosis","Light Chain Cardiac Amyloidosis","NOT_YET_RECRUITING","2026-09-17",{"date":133,"type":134},"2026-09-23","ACTUAL",{"date":136,"type":121},"2026-08-31",{"date":138,"type":121},"2028-12-31",{"name":5,"class":6},1]