[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637123":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Norroy Bioscience Co., LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68-Ga-NYM032","EXPERIMENTAL",null,[13],"Drug: 68-Ga-NYM032",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","IV injection",[9],[20,39],{"facility":21,"status":22,"city":23,"state":24,"zip":11,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Affiliated Drum Tower Hospital, Medical School of Nanjing University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":28,"coordinates":29},"Point",[30,31],118.77778,32.06167,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Hongqian Guo, MD","CONTACT","13605171690","gymwpi@126.com",{"facility":40,"status":22,"city":41,"state":24,"zip":11,"country":25,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"Affiliated Hospital of Jiangnan University","Wuxi",{"type":28,"coordinates":43},[44,45],120.28857,31.56887,{"lat":45,"lon":44},[48],{"name":49,"role":36,"phone":50,"phoneExt":11,"email":51},"Chunjing Yu, MD","15312238622","ycj_wxd1978@163.com",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100637123","phase-3-investigating-the-safety-and-diagnostic-performance-of-68ga-nym032-injection-petct-in-men-with-newly-diagnosed-prostate-cancer-100637123",false,"NCT07615101","Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET\u002FCT in Men With Newly Diagnosed Prostate Cancer.","Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET\u002FCT in Men With Newly Diagnosed Prostate Cancer.","Inclusion Criteria:\n\n1. Patient is male and aged \\>18 years old.\n2. Biopsy proven prostate adenocarcinoma.\n3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).\n4. ECOG performance status 0-2; expected survival ≥ 6 months.\n\n6\\. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* 1\\. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.\n\n  2\\. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.\n\n  3\\. Known hypersensitivity to the active ingredient or excipients of the study drug.\n\n  4\\. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.\n\n  5\\. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.","MALE","18 Years",{"count":64,"type":65},365,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.",[71],"Prostate Cancer (Diagnosis)","2026-08-13",{"date":74,"type":75},"2026-08-17","ACTUAL",{"date":77,"type":75},"2026-08-06",{"date":79,"type":65},"2027-07-30",{"name":5,"class":6},2]