[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636282":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adults With ARVC","EXPERIMENTAL","Participants in this single-arm diagnostic imaging study will undergo protocol-specified 68Ga-DOTA-SA-FAPI PET\u002FCT for assessment of myocardial fibroblast-related remodeling in arrhythmogenic right ventricular cardiomyopathy. All participants will also undergo clinical evaluation, 12-lead electrocardiography, transthoracic echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings, followed by 6 months of protocol-defined clinical follow-up.",[13],"Diagnostic Test: 68Ga-DOTA-SA-FAPI PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","68Ga-DOTA-SA-FAPI PET\u002FCT","Protocol-specified 68Ga-DOTA-SA-FAPI positron emission tomography\u002Fcomputed tomography performed for assessment of myocardial fibroblast-related remodeling in patients with arrhythmogenic right ventricular cardiomyopathy. The imaging protocol includes intravenous administration of approximately 150-200 MBq of 68Ga-DOTA-SA-FAPI, an uptake period of 40-60 minutes, low-dose CT for attenuation correction and anatomical localization, and thoracic PET acquisition for cardiac assessment.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sukru Arslan, MD, Associate Professor","CONTACT","+90 555 623 2606","sukru.arslan@iuc.edu.tr",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Sahra Asena Balcioglu, MD","+90 530 443 3766","sahra.balcioglu@iuc.edu.tr",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":20,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Istanbul University-Cerrahpasa Institute of Cardiology","RECRUITING","Istanbul","Fatih","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],28.94966,41.01384,{"lat":42,"lon":41},[45,46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":20,"phoneExt":20,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Şükrü Arslan","MD, Associate Professor","100636282","fapi-petct-imaging-in-arrhythmogenic-right-ventricular-cardiomyopathy-arvc-fapi-arvc-100636282",false,"NCT07563660","FAPI PET\u002FCT Imaging in Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) (FAPI-ARVC))","Incremental Diagnostic and Prognostic Value of 68Ga-DOTA-SA-FAPI PET\u002FCT Imaging in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","FAPI-ARVC","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Established diagnosis of arrhythmogenic right ventricular cardiomyopathy according to the 2010 Revised Task Force Criteria and\u002For the Padua criteria\n* Under active follow-up at the study center\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* History of malignancy\n* Severe renal impairment\n* Severe hepatic impairment\n* Pregnancy or breastfeeding\n* Prior 68Ga-DOTA-SA-FAPI PET\u002FCT imaging\n* Inability or unwillingness to provide written informed consent\n* Any medical, clinical, or logistical condition that, in the opinion of the investigators, could interfere with study participation, image interpretation, or completion of follow-up","ALL","18 Years",{"count":62,"type":63},15,"ESTIMATED","INTERVENTIONAL",[66],"NA","Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited heart muscle disease associated with fibrofatty myocardial replacement, ventricular arrhythmias, and an increased risk of sudden cardiac death. Although current diagnostic approaches, including the 2010 Task Force Criteria and the Padua criteria, improve recognition of the disease, early diagnosis remains challenging, particularly when structural abnormalities are subtle or absent on conventional imaging. Echocardiography and cardiac magnetic resonance imaging are central to evaluation, but their sensitivity for early or active fibrotic remodeling may be limited. This limitation may be particularly relevant in patients who are unable to undergo cardiac magnetic resonance imaging, in whom 68Ga-DOTA-SA-FAPI PET\u002FCT may provide complementary diagnostic information.\n\nThis prospective single-group diagnostic imaging study aims to investigate the incremental value of protocol-specified 68Ga-DOTA-SA-FAPI PET\u002FCT imaging in patients with ARVC. FAPI PET\u002FCT is a novel molecular imaging method that targets activated fibroblasts and may allow non-invasive detection of active myocardial fibrosis.Fifteen adult patients with an established diagnosis of ARVC will undergo protocol-specified 68Ga-DOTA-SA-FAPI PET\u002FCT imaging in addition to clinical evaluation, electrocardiography, echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings. FAPI PET\u002FCT findings will be compared with conventional diagnostic criteria and other clinical and imaging parameters, including previously available cardiac magnetic resonance imaging findings. Participants will also be followed clinically for 6 months after imaging to explore possible associations between FAPI uptake and short-term clinical outcomes, including arrhythmic events, ventricular function, and laboratory markers.\n\nThe study is expected to provide preliminary evidence on whether 68Ga-DOTA-SA-FAPI PET\u002FCT may improve the detection of myocardial fibrosis and contribute to diagnostic assessment and risk stratification in ARVC. It may also help clarify the potential role of FAPI PET\u002FCT in patients who are unable to undergo cardiac magnetic resonance imaging. The findings may support future larger prospective studies in this field.",[69,70,71],"Arrhythmogenic Right Ventricular Cardiomyopathy","FAPI PET","Cardiac Magnetic Resonance Imaging",[69,73,74,75,76,77,71,78],"Fibroblast Activation Protein","Positron Emission Tomography Computed Tomography","Molecular Cardiac Imaging","Sudden Cardiac Death Risk Stratification","Inherited Cardiomyopathy","Myocardial Fibrosis","2026-04-30",{"date":81,"type":82},"2026-05-04","ACTUAL",{"date":84,"type":82},"2025-04-16",{"date":86,"type":63},"2026-10-26",{"name":5,"class":6},1]