[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SOFIE\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100609678","phase-3-using-18f-fapi-pet-to-detect-metastatic-disease-in-patients-that-have-gastric-or-esophageal-cancer-100609678",false,"NCT07217704","Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.","A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET\u002FCT for the Detection of Metastatic Disease in Adults With Gastric or Esophageal Cancer","FAPI-GO","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years.\n* Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Provided signed, written informed consent prior to any study-related procedures.\n* Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \\[¹⁸F\\]FAPI-74 administration.\n* For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, during the trial intervention period.\n\nExclusion Criteria:\n\n* Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.\n* Known hypersensitivity to \\[¹⁸F\\]FAPI-74.\n* Administration of another investigational diagnostic or therapeutic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.\n* Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.\n* Previous cancer (except basal cell carcinoma of the skin or in situ carcinoma of the cervix\u002Futerus (participants treated with curative intent and disease free for more than 5 years are permitted).\n* Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN\n* Renal function: GFR \\\u003C 30 mL\u002Fmin\n* Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).\n* Inability to undergo the PET\u002FCT scanning procedure.\n* Inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* Sarcoidosis\n* Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \\[¹⁸F\\]FAPI-74 PET\u002FCT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo \\[¹⁸F\\]FAPI-74 PET\u002FCT screening. SOC procedures and interventions will be captured during 3 months +\u002F-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \\[¹⁸F\\]FAPI-74 PET\u002FCT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \\[¹⁸F\\]FAPI-74 PET\u002FCT.",[27,28,29],"Esophageal Cancer","Gastric Cancer (GC)","Gastroesophageal Junction",[31,32,33,34,35,36],"FAP","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","FAPI","gastroesophageal cancer","PET","RECRUITING","2026-06-26",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"2025-11-14",{"date":45,"type":21},"2027-08-30",{"name":47,"class":48},"SOFIE","INDUSTRY",15,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100609679","phase-3-using-18f-fapi-pet-to-detect-metastatic-disease-in-patients-that-have-pancreatic-ductal-adenocarcinoma-pdac-100609679","NCT07217717","Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET\u002FCT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma","FAPI-PRO","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years.\n* Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2:\n* Provided signed, written informed consent obtained prior to any study-related procedures.\n* Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \\[¹⁸F\\]FAPI-74 administration.\n* For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner , during the trial intervention period.\n\nExclusion Criteria:\n\n* Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.\n* Known hypersensitivity to \\[¹⁸F\\]FAPI-74.\n* Administration of another investigational therapeutic or diagnostic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.\n* Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.\n* Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix\u002Futerus). Participants treated with curative intent and disease-free for more than 5 years are permitted.\n* Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN\n* Renal function: GFR \\\u003C 30 mL\u002Fmin\n* Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)\n* Inability to undergo the PET\u002FCT scanning procedure.\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Sarcoidosis\n* Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.",{"count":20,"type":21},[24],"This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \\[¹⁸F\\]FAPI-74 PET\u002FCT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \\[¹⁸F\\]FAPI-74 PET\u002FCT screening. SOC procedures and interventions will be captured during 3 months +\u002F-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \\[¹⁸F\\]FAPI-74 PET\u002FCT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \\[¹⁸F\\]FAPI-74 PET\u002FCT.",[62],"Pancreatic Ductal Adenocarcinoma (PDAC)",[64,31,34,36,32,33],"PDAC",{"date":40,"type":41},{"date":67,"type":41},"2025-12-11",{"date":69,"type":21},"2027-12-31",{"name":47,"class":48},""]