[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Norroy Bioscience Co., LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},365,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Prostate Cancer (Diagnosis)","RECRUITING","2026-08-13",{"date":30,"type":31},"2026-08-17","ACTUAL",{"date":33,"type":31},"2026-08-06",{"date":35,"type":20},"2027-07-30",{"name":37,"class":38},"Norroy Bioscience Co., LTD","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100652008","phase-1-evaluation-of-safety-pharmacokinetics-distributionradiation-safety-and-sensitivityspecificity-of-petct-imaging-with-68ga-nym096-in-participants-with-irm-100652008","NCT07768306","Evaluation of Safety, Pharmacokinetics, Distribution，Radiation Safety and Sensitivity\u002FSpecificity of PET\u002FCT Imaging With 68Ga-NYM096 in Participants With IRM","A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution，Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses","Inclusion Criteria:\n\n1. Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096.\n2. Age ≥18 years at the time of signing the informed consent form;\n3. ECOG score 0-2;\n4. Life expectancy ≥6 months;\n5. Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;\n6. Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures\n\nExclusion Criteria:\n\n1. A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;\n2. Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.\n3. Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.\n4. Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET\u002FCT.\n5. Received other investigational drugs before 68Ga-NYM096 PET\u002FCT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.\n6. Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.\n7. Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen \\[HBsAg\\] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus \\[HCV\\] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).\n8. Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.\n9. Other situations where the investigator considers the participant unsuitable for this study","ALL",{"count":49,"type":20},20,[51],"PHASE1","68Ga-NYM096 is a carbonic anhydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for the detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study is to evaluate the safety, pharmacokinetics, radioactivity distribution, radiation safety and preliminary diagnostic performance in participants with indeterminate renal masses (IRM)",[54],"Clear Cell Renal Cell Carcinoma (ccRCC)",[56,57],"indeterminate renal masses","Suspected Renal Clear Cell Carcinoma","NOT_YET_RECRUITING","2026-08-12",{"date":30,"type":31},{"date":62,"type":20},"2026-09",{"date":64,"type":20},"2027-04",{"name":37,"class":38},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100642806","phase-3-this-study-evaluates-the-diagnostic-performance-and-safety-of-68ga-nym032-petct-imaging-in-patients-with-suspected-recurrence-of-prostate-cancer-100642806","NCT07649122","This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET\u002FCT Imaging in Patients With Suspected Recurrence of Prostate Cancer.","A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET\u002FCT Imaging Results in Men With Suspected Recurrence of Prostate Cancer","Inclusion Criteria:\n\n1. Patient is male and aged \\>18 years old.\n2. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and\u002For radiotherapy and\u002For other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria):\n\n   1. Post-radical prostatectomy (RP): PSA ≥0.2 ng\u002FmL on two consecutive measurements obtained ≥6 weeks after surgery;\n   2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng\u002FmL above the PSA nadir;\n   3. Participants with recurrence after other treatments: PSA rise ≥2 ng\u002FmL above the PSA nadir.\n3. ECOG performance status 0-2; expected survival ≥ 6 months.\n4. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. 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.\n2. 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.\n3. Known hypersensitivity to the active ingredient or excipients of the study drug.\n4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.\n5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.",{"count":74,"type":20},232,[23],"This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET\u002FCT imaging in patients with suspected recurrence of prostate cancer.",[78],"Prostate Cancer","2026-06-11",{"date":81,"type":31},"2026-06-16",{"date":83,"type":20},"2026-06-30",{"date":85,"type":20},"2028-07-31",{"name":37,"class":38},""]