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MD",{"facility":271,"status":37,"city":272,"state":273,"zip":274,"country":41,"countryCode":42,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"University of Pennsylvania, Perelman School of Medicine","Philadelphia","Pennsylvania","19104",{"type":44,"coordinates":276},[277,278],-75.16362,39.95238,{"lat":278,"lon":277},[281,285],{"name":282,"role":28,"phone":283,"phoneExt":11,"email":284},"Erin Schubert","215-573-6569","Erin.schubert@pennmedicine.upenn.edu",{"name":286,"role":59,"phone":11,"phoneExt":11,"email":11},"Mark Sellmyer, MD, PhD",{"type":288,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609679","phase-3-using-18f-fapi-pet-to-detect-metastatic-disease-in-patients-that-have-pancreatic-ductal-adenocarcinoma-pdac-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":300,"type":301},200,"ESTIMATED","INTERVENTIONAL",[304],"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.",[307],"Pancreatic Ductal Adenocarcinoma (PDAC)",[309,310,311,312,313,314],"PDAC","FAP","FAPI","PET","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","2026-06-26",{"date":317,"type":318},"2026-06-30","ACTUAL",{"date":320,"type":318},"2025-12-11",{"date":322,"type":301},"2027-12-31",{"name":5,"class":6},15]