[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06305728":3,"trial-entities:NCT06305728":163,"trial-summary:NCT06305728":166},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":15,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":45,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":15,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":68,"locations":71,"central_contacts":149,"overall_officials":156,"references":159,"see_also_links":160},"NCT06305728","23-367","Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms","Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms","RECRUITING","2030-03-04","2026-08","2026-08-25","2024-03-04","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma\u002FPDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:\n\n* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1\n* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)",[18],"Pancreatic Cyst",[18,13,5],"OBSERVATIONAL",[],{"count":23,"type":24},25,"ESTIMATED",[26,34,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":32},"DIAGNOSTIC_TEST","89Zr-DFO-HuMab-5B1 immunoPET","Participants who choose to will undergo immunoPET before surgery.",[31],"High Risk Pancreatic Cystic Neoplasm",[33],"immunoPET",{"type":27,"name":35,"description":36,"armGroupLabels":37},"HP MRI","Participants who choose to will undergo HP MRI before surgery.",[31],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"COMBINATION_PRODUCT","Blood assay","Will be drawn within 6 weeks of surgery and annually as post operative care",[31],[44],"CA19-.9",[46],{"measure":47,"description":48,"timeFrame":49},"Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma","Assess preliminary sensitivity and specificity if the immunoPET is able to identify the presence or absence of adenocarcinoma or high-grade dysplasia in participants who are scheduled to undergo surgical resection.","up to 1 year",[],"ALL","18 Years",false,{"inclusion":55,"exclusion":59,"raw_text":67},[56,57,58],"Men and women aged \\>18 years","Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection","Able to provide informed consent",[60,61,62,63,64,65,66],"Pathologic evidence of pancreatic cancer","Pregnant or breast-feeding patients","Refusal or inability to tolerate scan (eg anxiety or claustrophobia)","Inability to lay flat or meet the standard requirements of traditional MRI","Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay","Renal function with Creatinine \\> 1.5 x ULN or creatinine clearance \\\u003C 60 mL\u002Fmin, from assays obtained within 6 weeks prior to study enrollment","Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.","Inclusion Criteria:\n\n* Men and women aged \\>18 years\n* Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pathologic evidence of pancreatic cancer\n* Pregnant or breast-feeding patients\n* Refusal or inability to tolerate scan (eg anxiety or claustrophobia)\n* Inability to lay flat or meet the standard requirements of traditional MRI\n* Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay\n\n  1. Bilirubin \\> 1.5 x ULN\n  2. AST\u002FALT \\> 2.5 x ULN\n  3. Albumin \\\u003C 3 g\u002FdL\n  4. GGT \\> 2.5 x ULN if Alkaline Phosphatase \\> 2.5 x ULN\n* Renal function with Creatinine \\> 1.5 x ULN or creatinine clearance \\\u003C 60 mL\u002Fmin, from assays obtained within 6 weeks prior to study enrollment\n* Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.",[69,70],"ADULT","OLDER_ADULT",[72,86,95,104,114,123,131,139],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":83},"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[79],{"name":80,"role":81,"phone":82},"Kevin Soares, MD","CONTACT","212-639-3195",{"lat":84,"lon":85},40.70621,-74.54932,{"facility":87,"status":8,"city":88,"state":75,"zip":89,"country":77,"contacts":90,"geoPoint":92},"Memorial Sloan Kettering Monmouth (Limited protocol activities)","Middletown","07748",[91],{"name":80,"role":81,"phone":82},{"lat":93,"lon":94},40.39428,-74.11709,{"facility":96,"status":8,"city":97,"state":75,"zip":98,"country":77,"contacts":99,"geoPoint":101},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[100],{"name":80,"role":81,"phone":82},{"lat":102,"lon":103},41.04676,-74.02292,{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":77,"contacts":109,"geoPoint":111},"Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)","Commack","New York","11725",[110],{"name":80,"role":81,"phone":82},{"lat":112,"lon":113},40.84288,-73.29289,{"facility":115,"status":8,"city":116,"state":107,"zip":117,"country":77,"contacts":118,"geoPoint":120},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[119],{"name":80,"role":81,"phone":82},{"lat":121,"lon":122},40.96899,-73.71263,{"facility":124,"status":8,"city":107,"state":107,"zip":125,"country":77,"contacts":126,"geoPoint":128},"Memorial Sloan Kettering Cancer Center (All protocol activites)","10065",[127],{"name":80,"role":81,"phone":82},{"lat":129,"lon":130},40.71427,-74.00597,{"facility":132,"status":133,"city":107,"state":107,"zip":125,"country":77,"contacts":134,"geoPoint":138},"Weill Cornell Medical Center (Specimen Analysis Only)","NOT_YET_RECRUITING",[135],{"name":136,"role":81,"phone":137},"David Lyden, MD","212-746-6565",{"lat":129,"lon":130},{"facility":140,"status":8,"city":141,"state":107,"zip":142,"country":77,"contacts":143,"geoPoint":146},"Memorial Sloan Kettering Nassau (Limited Protocol Activites)","Rockville Centre","11553",[144],{"name":145,"role":81,"phone":82},"Kevin Soares, PhD",{"lat":147,"lon":148},40.65871,-73.64124,[150,152],{"name":80,"role":81,"phone":82,"email":151},"soaresk@mskcc.org",{"name":153,"role":81,"phone":154,"email":155},"David Kelson, MD","646-888-4179","kelsend@MSKCC.ORG",[157],{"name":80,"affiliation":13,"role":158},"PRINCIPAL_INVESTIGATOR",[],[161],{"label":13,"url":162},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":164,"biomarkers":165},[18],[],{"nct_id":4,"found":167,"summary":168,"prompt_version":178},true,{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is an observational study planning to enroll 25 participants. It is not specified if it is randomized or blinded.","completed","Early Detection of Pancreatic Cancer in Patients with Pancreatic Cysts","This study aims to find better ways to detect pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer, early in people who have pancreatic cysts. Researchers are testing if a combination of special imaging scans and blood tests can effectively identify PDAC. The imaging tests include an ImmunoPET scan using 89Zr-DFO-HuMab-5B1 and an HP MRI (hyperpolarized pyruvate magnetic resonance imaging) scan. Blood tests will also be collected. The main goal is to see how well the ImmunoPET scan can identify the presence or absence of PDAC. You may be eligible if you are over 18, have a high-risk pancreatic cyst needing surgery, and can give informed consent. The study is currently unclear on its recruitment status.","The study will measure the sensitivity of ImmunoPET to identify adenocarcinoma for up to 1 year.",116,"If you choose, you would undergo ImmunoPET and HP MRI scans before surgery. Blood samples will be drawn within 6 weeks of surgery and annually for post-operative care.","Not stated in the trial record.",[35],"v2"]