[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657275":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":42,"overallOfficials":26,"centralContacts":52,"locations":62,"responsibleParty":75,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":97,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Diagnostic efficacy","Diagnostic efficacy of 68Ga-NYM215 PET\u002FCT compared with 68Ga-DOTATATE PET\u002FCT in the same participant, assessed on both a per-patient and per-lesion basis. Per-patient analysis will compare lesion detection rate. Per-lesion analysis will compare lesion detection rate, lesion number, size, SUVmax, and tumor-to-background ratio (TBR).","At the time of paired PET\u002FCT imaging, within 1 week.",{"measure":14,"description":15,"timeFrame":16},"Safety","Adverse effects after radiotracer injection.","From radiotracer injection to 24 hours post-injection.",[18,22],{"measure":19,"description":20,"timeFrame":21},"Biodistribution","The biodistribution of 68Ga-NYM215 will be evaluated in the following organs: pituitary gland, parotids, thyroids, lungs, blood pool, liver, spleen, pancreas (head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands.","Through study completion, within 1 week.",{"measure":23,"description":24,"timeFrame":25},"Dosimetry","Absorbed dose for target organs, urinary bladder residence time, and whole-body effective dose were determined for 68Ga-NYM215.","Through study completion, an average of 6 months.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms that frequently overexpress somatostatin receptors (SSTRs), particularly SSTR subtype 2 (SSTR2), which provide specific targets for both imaging and therapy. As a somatostatin receptor agonist, 68Ga-DOTATATE PET\u002FCT is an established imaging modality for the detection, staging, restaging, and treatment selection of patients with NETs.\n\nSSTR antagonists may show lower physiologic uptake in abdominal organs and have demonstrated potential for improved lesion detection compared with SSTR agonists. 68Ga-NYM215 is a novel SSTR antagonist with high receptor affinity. In preclinical SSTR-positive animal models, 68Ga-NYM215 demonstrated favorable safety, biodistribution, and tumor uptake.The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of 68Ga-NYM215 in patients with NETs. And compare the diagnostic ability of 68Ga-NYM215 with 68Ga-DOTATATE PET\u002FCT.\n\nThis prospective study will enroll patients with pathologically confirmed NENs. All participants will undergo both 68Ga-NYM215 PET\u002FCT and 68Ga-DOTATATE PET\u002FCT. For radiation dosimetry, the first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET\u002FCT at 40 to 60 minutes after administration. All participants will undergo whole-body 68Ga-DOTATATE PET\u002FCT at 40 to 60 minutes after radiotracer administration. The two PET\u002FCT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.\n\nResults were determined by two nuclear medicine physicians through consensus, with disagreements adjudicated through concurrent image interpretation involving a third senior physician. For each examination, lesions will be documented according to number, anatomical location, size, SUVmax, and tumor-to-background ratio (TBR).\n\nThe study will explore the safety, biodistribution, radiation dosimetry, and diagnostic performance of 68Ga-NYM215 PET\u002FCT. A head-to-head comparison with 68Ga-DOTATATE PET\u002FCT will be performed to compare the diagnostic performance at both the patient and lesion levels.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"68Ga-NYM215 and Comparator 68Ga-DOTATATE PET\u002FCT","EXPERIMENTAL","Patients will perform a 68Ga-NYM215 PET\u002FCT as well as a 68Ga-DOTATATE PET\u002FCT.",[40,41],"Diagnostic Test: 68Ga-NYM215 PET\u002FCT","Diagnostic Test: 68Ga-DOTATATE PET\u002FCT",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"DIAGNOSTIC_TEST","68Ga-NYM215 PET\u002FCT","40 patients will be enrolled in this arm. Each patients will be injected with approximately 3mCi 68Ga-NYM215. The first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET\u002FCT at 40 to 60 minutes after administration.",[36],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":26},"68Ga-DOTATATE PET\u002FCT","Each patients will be injected with approximately 3mCi 68Ga-DOTATATE. All participants will undergo whole-body 68Ga-DOTATATE PET\u002FCT at 40 to 60 minutes after radiotracer administration. The two PET\u002FCT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.",[36],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":26,"email":57},"Meixi Liu, MD","CONTACT","+86-15010405355","meixiliu_pumc@126.com",{"name":59,"role":55,"phone":60,"phoneExt":26,"email":61},"Huo Li, MD","+86-13910801986","huoli@pumch.cn",[63],{"facility":5,"status":26,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":26},"Beijing","Beijing Municipality","100730","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100657275","phase-1-68ga-nym215-in-nens-100657275",false,"NCT07835906","68Ga-NYM215 in NENs","Safety, Biodistribution, Dosimetry of 68Ga-NYM215 PET\u002FCT and Head-to-head Comparison With 68Ga-DOTATATE PET\u002FCT in Patients With Neuroendocrine Neoplasms: A Prospective Study","Inclusion Criteria:\n\n* Aged 18 to 80 years.\n* Histopathologically confirmed neuroendocrine tumor.\n* At least one suspected lesion based on other imaging findings or clinical assessment.\n\nExclusion Criteria:\n\n* Combined with other types of tumors.\n* Severe liver or renal dysfunction (ALT\u002FAST≥5 ULN, GFR#30ml\u002Fmin).\n* Active infection.\n* Pregnant or breastfeeding women.\n* Inability to undergo PET\u002FCT imaging.","ALL","18 Years","80 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET\u002FCT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET\u002FCT will assess the diagnostic performance of 68Ga-NYM215 PET\u002FCT at both the patient and lesion levels.",[96],"Neuroendocrine Neoplasms","NOT_YET_RECRUITING","2026-09-17",{"date":100,"type":101},"2026-09-23","ACTUAL",{"date":103,"type":89},"2026-09-10",{"date":105,"type":89},"2027-10-20",{"name":5,"class":6},1]