[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217717":3,"trial-entities:NCT07217717":341,"trial-summary:NCT07217717":345},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":64,"minimum_age":65,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":88,"locations":91,"central_contacts":326,"overall_officials":334,"references":339,"see_also_links":340},"NCT07217717","18FFAPI-2025P3-PDAC","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","RECRUITING","2027-12-31","2026-01","2026-09-17","2025-12-11","SOFIE","INDUSTRY",false,"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.",null,[19],"Pancreatic Ductal Adenocarcinoma (PDAC)",[21,22,23,24,25,26],"PDAC","FAP","FAPI","PET","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","INTERVENTIONAL","DIAGNOSTIC",[30],"PHASE3",{"count":32,"type":33},200,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","[18F]FAPI-74 PET\u002FCT","\\[18F\\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma.",[40],"Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74",[42],{"measure":43,"description":44,"timeFrame":45},"Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference","To evaluate the diagnostic performance of \\[¹⁸F\\]FAPI-74 PET\u002FCT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).","Time Frame: From enrollment to the end of treatment after 3 month follow up",[47,51,55,57,60,62],{"measure":48,"description":49,"timeFrame":50},"Incidence and severity of adverse events using CTCAE v5.","To assess the safety profile of \\[¹⁸F\\]FAPI-74 PET\u002FCT.","24-72 hours post-injection",{"measure":52,"description":53,"timeFrame":54},"Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement","To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease","From enrollment to the end of treatment after 3 month follow up",{"measure":56,"description":49,"timeFrame":50},"Number of participants with treatment-related adverse events as assessed by body temperature changes",{"measure":58,"description":59,"timeFrame":50},"Number of participants with treatment-related adverse events as assessed by blood pressure changes","To assess the safety profile of \\[¹⁸F\\]FAPI-74",{"measure":61,"description":59,"timeFrame":50},"Number of participants with treatment-related adverse events as assessed by respiration rate",{"measure":63,"description":59,"timeFrame":50},"Number of participants with treatment-related adverse events as assessed by pulse rate","ALL","18 Years",{"inclusion":67,"exclusion":74,"raw_text":87},[68,69,70,71,72,73],"Male and female adults ≥ 18 years.","Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.","Eastern Cooperative Oncology Group (ECOG) performance status ≤2:","Provided signed, written informed consent obtained prior to any study-related procedures.","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.","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.",[75,76,77,78,79,80,81,82,83,84,85,86],"Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.","Known hypersensitivity to \\[¹⁸F\\]FAPI-74.","Administration of another investigational therapeutic or diagnostic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.","Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.","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.","Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN","Renal function: GFR \\\u003C 30 mL\u002Fmin","Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)","Inability to undergo the PET\u002FCT scanning procedure.","Inflammatory bowel disease (Crohn's disease or ulcerative colitis)","Sarcoidosis","Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.","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.",[89,90],"ADULT","OLDER_ADULT",[92,113,127,141,155,169,184,199,214,228,243,257,268,283,296,311],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":110},"Helios CR Inc.\u002FRadNet","Cerritos","California","90703","United States",[99,104,107],{"name":100,"role":101,"phone":102,"email":103},"Sabrina Mora","CONTACT","562-693-4477","Sabrina.mora@heliosclinical.com",{"name":105,"role":101,"email":106},"Alexis Velasco","alexis.velasco@heliosclinical.com",{"name":108,"role":109},"Omkar Marathe, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},33.85835,-118.06479,{"facility":114,"status":8,"city":115,"state":95,"zip":116,"country":97,"contacts":117,"geoPoint":124},"City of Hope National Cancer Center","Duarte","91010",[118,122],{"name":119,"role":101,"phone":120,"email":121},"Miranda Qian","(626) 218-3533","lqian@coh.org",{"name":123,"role":109},"Yufei Liu, M.D, Ph.D",{"lat":125,"lon":126},34.13945,-117.97729,{"facility":128,"status":8,"city":129,"state":95,"zip":130,"country":97,"contacts":131,"geoPoint":138},"Hoag Memorial Hospital","Irvine","92618",[132,136],{"name":133,"role":101,"phone":134,"email":135},"Beth Thomsen","949-557-0285","Beth.thomsen@hoag.org",{"name":137,"role":109},"Gary Ulaner, MD",{"lat":139,"lon":140},33.66946,-117.82311,{"facility":142,"status":8,"city":143,"state":95,"zip":144,"country":97,"contacts":145,"geoPoint":152},"UCLA","Los Angeles","90095",[146,150],{"name":147,"role":101,"phone":148,"email":149},"Steven Stokes","310 206-7436","SStokes@mednet.ucla.edu",{"name":151,"role":109},"Mark Girgis, MD",{"lat":153,"lon":154},34.05223,-118.24368,{"facility":156,"status":8,"city":157,"state":95,"zip":158,"country":97,"contacts":159,"geoPoint":166},"Stanford University","Stanford","94305",[160,164],{"name":161,"role":101,"phone":162,"email":163},"Kavin Tamizhmani","(650)-497-6046","ktamizhm@stanford.edu",{"name":165,"role":109},"Matteo Novello, MD",{"lat":167,"lon":168},37.42411,-122.16608,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":97,"contacts":174,"geoPoint":181},"Moffit Cancer Center","Tampa","Florida","33612",[175,179],{"name":176,"role":101,"phone":177,"email":178},"Jacqueline Guillermo Adams","813-745-2468","Jacqueline.GuillermoAdams@moffitt.org",{"name":180,"role":109},"Ghassan El-Haddad, MD",{"lat":182,"lon":183},27.94752,-82.45843,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":97,"contacts":189,"geoPoint":196},"Indiana University Health University Hospital","Indianapolis","Indiana","46202",[190,194],{"name":191,"role":101,"phone":192,"email":193},"Eric Grubbs","(317) 274-2584","eegrubbs@iu.edu",{"name":195,"role":109},"Cindy Yuan, MD PhD",{"lat":197,"lon":198},39.76838,-86.15804,{"facility":200,"status":8,"city":201,"state":202,"zip":203,"country":97,"contacts":204,"geoPoint":211},"Massachusetts General Hospital","Boston","Massachusetts","02114",[205,209],{"name":206,"role":101,"phone":207,"email":208},"Isabelle Lin","617-643-6837","ilin4@mgh.harvard.edu",{"name":210,"role":109},"Shadi Esfahani, MD",{"lat":212,"lon":213},42.35843,-71.05977,{"facility":215,"status":8,"city":216,"state":202,"zip":217,"country":97,"contacts":218,"geoPoint":225},"UMass\u002FShields","Worcester","01655",[219,223],{"name":220,"role":101,"phone":221,"email":222},"Sara Schiller","774-548-1090","sara.schiller1@umassmed.edu",{"name":224,"role":109},"Elisa Franquet-Elia, MD",{"lat":226,"lon":227},42.26259,-71.80229,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":97,"contacts":233,"geoPoint":240},"Mayo Clinic Rochester","Rochester","Minnesota","55905",[234,238],{"name":235,"role":101,"phone":236,"email":237},"Kera Delaney","507-293-2227","delaney.kera@mayo.edu",{"name":239,"role":109},"Ajit H Goenka, MD",{"lat":241,"lon":242},44.02163,-92.4699,{"facility":244,"status":8,"city":245,"state":245,"zip":246,"country":97,"contacts":247,"geoPoint":254},"Icahn School of Medicine at Mount Sinai","New York","10029",[248,252],{"name":249,"role":101,"phone":250,"email":251},"Ilda Bander","212-241-0763","Ilda.bander@mountsinai.org",{"name":253,"role":109},"Sampanna Rayamajhi, MD",{"lat":255,"lon":256},40.71427,-74.00597,{"facility":258,"status":8,"city":245,"state":245,"zip":259,"country":97,"contacts":260,"geoPoint":267},"Memorial Sloan Kettering Cancer Center","10065",[261,265],{"name":262,"role":101,"phone":263,"email":264},"Jordayna Francois","(646)888-6819","francoij@mskcc.org",{"name":266,"role":109},"Aria Razmari, MD",{"lat":255,"lon":256},{"facility":269,"status":8,"city":270,"state":271,"zip":272,"country":97,"contacts":273,"geoPoint":280},"Cleveland Clinic","Cleveland","Ohio","44195",[274,278],{"name":275,"role":101,"phone":276,"email":277},"Molly Haberkorn","216-445-6434","HABERKS@ccf.org",{"name":279,"role":109},"Nicholas Austin, DO",{"lat":281,"lon":282},41.4995,-81.69541,{"facility":284,"status":8,"city":284,"state":271,"zip":285,"country":97,"contacts":286,"geoPoint":293},"Kettering","45429",[287,291],{"name":288,"role":101,"phone":289,"email":290},"Kathren Garber","937-395-8390","kathren.garber@ketteringhealth.org",{"name":292,"role":109},"Arif Sheikh, MD",{"lat":294,"lon":295},39.6895,-84.16883,{"facility":297,"status":8,"city":298,"state":299,"zip":300,"country":97,"contacts":301,"geoPoint":308},"University of Pennsylvania, Perelman School of Medicine","Philadelphia","Pennsylvania","19104",[302,306],{"name":303,"role":101,"phone":304,"email":305},"Erin Schubert","215-573-6569","Erin.schubert@pennmedicine.upenn.edu",{"name":307,"role":109},"Mark Sellmyer, MD, PhD",{"lat":309,"lon":310},39.95238,-75.16362,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":97,"contacts":316,"geoPoint":323},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[317,321],{"name":318,"role":101,"phone":319,"email":320},"Kyersten Hoene","9209796340","khoene@mcw.edu",{"name":322,"role":109},"Michael Holt, MD",{"lat":324,"lon":325},43.0389,-87.90647,[327,331],{"name":328,"role":101,"phone":329,"email":330},"Alex Osipova","1-800-753-5368","Alex.osipova@sofie.com",{"name":332,"role":101,"phone":329,"email":333},"Bridget Adams","bridget.adams@sofie.com",[335],{"name":336,"affiliation":337,"role":338},"Sherly Mosessian, Ph.D","Sofie Co.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":342,"biomarkers":344},[343],"Pancreatic Ductal Adenocarcinoma",[],{"nct_id":4,"found":346,"summary":347,"prompt_version":357},true,{"design":348,"status":349,"heading":350,"summary":351,"follow_up":352,"word_count":353,"commitments":354,"compensation":355,"drugs_mentioned":356},"This is a multi-site, open-label (meaning you and your doctors will know what treatment you are receiving), non-randomized study. It will involve 200 participants.","completed","Detecting Metastatic Pancreatic Cancer with 18F-FAPI PET","This study is looking at how well a special imaging test, called [18F]FAPI-74 PET\u002FCT, can find pancreatic cancer that has spread to other parts of the body (metastatic disease). [18F]FAPI-74 is a diagnostic agent that helps light up certain cancer cells and cells around them during a PET scan. You may be able to join if you are an adult (18 or older) with confirmed pancreatic ductal adenocarcinoma (PDAC) and are undergoing evaluation for treatment. The researchers want to see how accurately this scan can detect metastatic disease compared to standard methods. The study plans to enroll 200 participants.","Participants will be followed for 3 months +\u002F- 14 days after the injection to capture standard of care procedures and interventions.",99,"After screening, you will receive a single dose of [18F]FAPI-74 and undergo a PET\u002FCT scan. Your standard of care (SOC) procedures and interventions will be recorded for about 3 months after the injection.","Not stated in the trial record.",[37],"v2"]