[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586534":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":42,"collaborators":44,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"18F-NY104 PET\u002FCT scan",null,[12],"Radiation: 18F-NY104 PET\u002FCT",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"RADIATION","18F-NY104 PET\u002FCT","The radionuclide ¹⁸F will serve as the tracer in this study. NY104 will be labeled with \\[¹⁸F\\]AlF to form the ¹⁸F-NY104 injection for use in this research.All participants will undergo ¹⁸F-NY104 PET scan.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"guang Zhen Wang","CONTACT","＋86-0532-82913318","wangzhenguang@qde.edu.cn",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Qingdao","Shandong","China","CN",{"type":33,"coordinates":34},"Point",[35,36],120.38042,36.06488,{"lat":36,"lon":35},[39],{"name":40,"role":22,"phone":41,"phoneExt":10,"email":24},"Jie Guang Yang","0532-82913318",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[45,47,49,52],{"name":46,"class":6},"Qianfoshan Hospital",{"name":48,"class":6},"Weifang People's Hospital",{"name":50,"class":51},"Zibo Central Hospital","OTHER_GOV",{"name":53,"class":6},"Jining Medical University","100586534","multicenter-study-of-18f-labeled-ny104-for-petct-imaging-in-renal-cell-carcinoma-100586534",false,"NCT06916624","Multicenter Study of 18F-Labeled NY104 for PET\u002FCT Imaging in Renal Cell Carcinoma","Inclusion Criteria:\n\n* (1)Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements; (2)Age 18-75 years; no gender restrictions; (3)Clinically diagnosed\u002Fsuspected as renal cell carcinoma or clinically diagnosed\u002Fsuspected recurrence\u002Fmetastasis after RCC treatment; (4)At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1); (5)ECOG performance status score of 0-2; (6)Laboratory parameters must meet:\n\n  1. Hematology: WBC ≥4.0×10⁹\u002FL or neutrophils ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL; PT or APTT ≤1.5×ULN (upper limit of normal);\n  2. Liver and kidney function: T-Bil ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;\n  3. Other routine tests within normal ranges or deemed acceptable by the investigator; (7)Expected survival ≥12 weeks; (8) Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives\u002Fagents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.\n\nExclusion Criteria:\n\n1. Recovery from major trauma (including surgery) within 4 weeks prior to study examination;\n2. Patients with systemic or local severe infections or other serious comorbidities;\n3. Severe hepatic or renal dysfunction;\n4. Refusal to participate in this clinical study;\n5. Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;\n6. Childbearing-aged male or female subjects who cannot adopt effective contraception;\n7. Women planning pregnancy, currently pregnant, or lactating;\n8. Patients unable or unwilling to undergo PET\u002FCT scanning;\n9. Other subjects deemed ineligible by the investigator.","ALL","18 Years","75 Years",{"count":64,"type":65},40,"ESTIMATED","OBSERVATIONAL","Study on the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET\u002FCT in diagnosing primary, recurrent, and metastatic lesions of renal cell carcinoma; and investigate the effect of oral low-dose CAIX inhibitor (Acetazolamide) on the tissue distribution of 18F-NY104 in renal cell carcinoma patients, particularly in the stomach and kidneys.",[69,70],"Renal Cell Carcinoma (RCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","2025-04-27",{"date":73,"type":74},"2025-04-29","ACTUAL",{"date":76,"type":74},"2025-04-12",{"date":78,"type":65},"2026-12",{"name":5,"class":6},1]