[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637123":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":19,"collaborators":11,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":11,"eligibilityCriteria":27,"healthyVolunteers":23,"sex":28,"minAge":29,"maxAge":11,"enrollmentInfo":30,"targetDuration":11,"studyType":33,"phases":34,"briefSummary":36,"conditions":37,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":45,"leadSponsor":47,"locationsCount":11},{"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],{"type":20,"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.","FEMALE","18 Days",{"count":31,"type":32},365,"ESTIMATED","INTERVENTIONAL",[35],"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.",[38],"Prostate Cancer (Diagnosis)","NOT_YET_RECRUITING","2026-05-28",{"date":42,"type":43},"2026-06-01","ACTUAL",{"date":42,"type":32},{"date":46,"type":32},"2027-07-30",{"name":5,"class":6}]