[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609679":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":286,"collaborators":11,"id":288,"slug":11,"hasResults":289,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":289,"sex":295,"minAge":296,"maxAge":11,"enrollmentInfo":297,"targetDuration":11,"studyType":300,"phases":301,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"SOFIE","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74","EXPERIMENTAL",null,[13],"Drug: [18F]FAPI-74 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MD",{"facility":270,"status":37,"city":271,"state":272,"zip":273,"country":41,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"University of Pennsylvania, Perelman School of Medicine","Philadelphia","Pennsylvania","19104",{"type":43,"coordinates":275},[276,277],-75.16362,39.95238,{"lat":277,"lon":276},[280,284],{"name":281,"role":28,"phone":282,"phoneExt":11,"email":283},"Erin Schubert","215-573-6569","Erin.schubert@pennmedicine.upenn.edu",{"name":285,"role":58,"phone":11,"phoneExt":11,"email":11},"Mark Sellmyer, MD, PhD",{"type":287,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609679",false,"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.","ALL","18 Years",{"count":298,"type":299},200,"ESTIMATED","INTERVENTIONAL",[302],"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 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.",[305],"Pancreatic Ductal Adenocarcinoma (PDAC)",[307,308,309,310,311,312],"PDAC","FAP","FAPI","PET","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","2026-06-26",{"date":315,"type":316},"2026-06-30","ACTUAL",{"date":318,"type":316},"2025-12-11",{"date":320,"type":299},"2027-12-31",{"name":5,"class":6},15]