[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609484":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":69,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":20,"enrollmentInfo":86,"targetDuration":20,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Advanced staged Malignant Melanoma","EXPERIMENTAL","Patients with advanced stage malignant melanoma with visible lesions on \\[18F\\]FDG PET\u002FCT referred for ICT at the Dept. of Oncology Herlev Hospital will be sought enrolled. Patients will undergo two \\[68Ga\\]Ga-FAPI-46 PET\u002FCT, which include injection with the experimental tracer \\[68Ga\\]Ga-FAPI-46. These scans are in addition to their standard imaging.",[13],"Drug: [68Ga]Ga-FAPI-46",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[68Ga]Ga-FAPI-46","Patients undergo two PET\u002FCTs with the experimental tracer \\[68Ga\\]Ga-FAPI-46 (drug).",[9],null,[22,49],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Herlev Universityhospital","RECRUITING","Herlev","Capital Region","2730","Denmark","DK",{"type":31,"coordinates":32},"Point",[33,34],12.43998,55.72366,{"lat":34,"lon":33},[37,42,46],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Inge Marie Svane, Professor, MD, PhD","CONTACT","+4538683868","inge.marie.svane@regionh.dk",{"name":43,"role":39,"phone":44,"phoneExt":20,"email":45},"Marie MK Stolberg, MD","+4535454416","marie.manon.krebs.krarup@regionh.dk",{"name":47,"role":48,"phone":20,"phoneExt":20,"email":20},"Inge Marie Svane, Professor, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":24,"city":51,"state":52,"zip":53,"country":28,"countryCode":29,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Rigshospitalet","Copenhagen","Ca","2100",{"type":31,"coordinates":55},[56,57],12.56553,55.67594,{"lat":57,"lon":56},[60,61,65,67],{"name":43,"role":39,"phone":44,"phoneExt":20,"email":45},{"name":62,"role":39,"phone":63,"phoneExt":20,"email":64},"Barbara M. Fischer, Professor, MD, Ph.D.","+4535453545","barbara.malene.fischer@regionh.dk",{"name":66,"role":48,"phone":20,"phoneExt":20,"email":20},"Barbara Malene Fischer, Professor, MD, Ph.D.",{"name":43,"role":68,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Barbara Malene Fischer","Professor, MD, Ph.D.",[74],{"name":75,"class":6},"Herlev Hospital","100609484","phase-2-68gaga-fapi-total-body-petct-for-better-and-faster-imaging-in-cancer-100609484",false,"NCT07215182","[68Ga]Ga-FAPI Total Body PET\u002FCT for Better and Faster Imaging in Cancer","[68Ga]Ga-FAPI PET\u002FCT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma","BEFAST","Inclusion Criteria:\n\n1. Male or female, \\>\u002F=18 years old\n2. Histological verified metastatic or locally advanced malignant melanoma\n3. Visible malignant lesions on \\[18F\\]FDG PET\u002FCT or CT\n4. Subjects must be considered inoperable\n5. Subjects must be considered medically suitable for ICT\n6. Subjects must be able to read and understand the patient information in Danish to give informed consent\n\nExclusion Criteria:\n\n1. Ocular or mucosal melanoma\n2. Other concurrent cancer disease\n3. Previous systemic oncological treatment with ICT\n4. Pregnancy or lactation\n5. Weight more than the maximum limit of a PET\u002FCT-scanner bed (140 kg)\n6. History of allergic reaction due to compounds similar to the chemical composition of \\[68Ga\\]Ga-FAPI- 46","ALL","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","The goal of this clinical trial is to investigate the use of the tracer \\[68Ga\\]Ga-FAPI-46 for PET\u002FCT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is:\n\n• Can \\[68Ga\\]Ga-FAPI-46 PET\u002FCT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker.\n\nResearchers will compare findings on the experimental \\[68Ga\\]Ga-FAPI-46 PET\u002FCT with findings on standard imaging (\\[18F\\]FDG PET\u002FCT).\n\nParticipants will undergo:\n\n* Two \\[68Ga\\]Ga-FAPI-46 PET\u002FCT scans: one before treatment initiation with ICT and one after three months.\n* Two blood samples\n* Passive follow-up 6 months after the last scan \\[68Ga\\]Ga-FAPI-46 PET\u002FCT",[94],"Malignant Melanoma Stage IV",[96,97,98,99],"FAPI PET\u002FCT","Immune checkpoint inhibitor therapy","malignant melanoma","response evaluation","2025-10-02",{"date":102,"type":103},"2025-10-10","ACTUAL",{"date":105,"type":103},"2025-08-15",{"date":107,"type":88},"2027-02-20",{"name":71,"class":6},2]