[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573756":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":152,"collaborators":25,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":25,"eligibilityCriteria":160,"healthyVolunteers":156,"sex":161,"minAge":162,"maxAge":25,"enrollmentInfo":163,"targetDuration":25,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm receiving the IP","EXPERIMENTAL","Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET\u002FCT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET\u002FCT imaging.\n\nFollowing pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken.\n\nOn Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET\u002FCT scan of the abdomen will occur on visit Day 5 (±2 days post administration \\[p.a.\\]) with nephrectomy to be performed any time after the PET\u002FCT imaging visit, but no later than 90 days p.a. 89Zr-TLX250.",[13],"Drug: 89Zr-TLX250 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","89Zr-TLX250 PET\u002FCT","89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg\u002Fmol.\n\n89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose.",[9],[21,22,23,24],"89Zr-DFO-girentuximab","89Zr-girentuximab","89Zr-DFO-TFP-GTX","89Zirconium-labelled girentuximab",null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Lily Nahidi","CONTACT","+61 3909 33871","lily.nahidi@telixpharma.com",[33,53,68,82,96,110,124,138],{"facility":34,"status":35,"city":36,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Beijing Cancer Hospital","RECRUITING","Beijing","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46,50],{"name":47,"role":29,"phone":48,"phoneExt":25,"email":49},"Peng Du","+86 13611376873","dupeng9000@126.com",{"name":51,"role":52,"phone":25,"phoneExt":25,"email":25},"Peng Du, Prof","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":55,"city":56,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Zhejiang Provincial People's Hospital","NOT_YET_RECRUITING","Hangzhou",{"type":40,"coordinates":58},[59,60],120.16142,30.29365,{"lat":60,"lon":59},[63,67],{"name":64,"role":29,"phone":65,"phoneExt":25,"email":66},"Xiaolong Qi","+86 15158885167","15158885167@163.com",{"name":64,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":69,"status":55,"city":70,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Union Hospital Tongji Medical College Huazhong University Of Science And Technology","Hubei",{"type":40,"coordinates":72},[73,74],120.41732,29.08114,{"lat":74,"lon":73},[77,81],{"name":78,"role":29,"phone":79,"phoneExt":25,"email":80},"Xiaoli Lan","+86 13886193262","HZSLXL@163.com",{"name":78,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":83,"status":55,"city":84,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Zhongshan Hospital, Fudan University","Shanghai",{"type":40,"coordinates":86},[87,88],121.45806,31.22222,{"lat":88,"lon":87},[91,95],{"name":92,"role":29,"phone":93,"phoneExt":25,"email":94},"Hongcheng Shi","+86 13681971579","shi.hongcheng@zs-hospital.sh.cn",{"name":92,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":97,"status":55,"city":98,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The First Affiliated Hospital of Soochow University","Suzhou",{"type":40,"coordinates":100},[101,102],120.59538,31.30408,{"lat":102,"lon":101},[105,109],{"name":106,"role":29,"phone":107,"phoneExt":25,"email":108},"Shibiao Sang","+86 13962112507","golf131701@sina.com",{"name":106,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":111,"status":55,"city":112,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Tianjin Cancer Hospital Airport Hospital","Tianjin",{"type":40,"coordinates":114},[115,116],117.17667,39.14222,{"lat":116,"lon":115},[119,123],{"name":120,"role":29,"phone":121,"phoneExt":25,"email":122},"Dong Dai","+86 18622000577","xiandao5502@163.com",{"name":120,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":125,"status":55,"city":126,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Affiliated Hospital Of Jiangnan University","Wuxi",{"type":40,"coordinates":128},[129,130],120.28857,31.56887,{"lat":130,"lon":129},[133,137],{"name":134,"role":29,"phone":135,"phoneExt":25,"email":136},"Chunjing Yu","+86 15312238622","ycj_wxd1978@163.com",{"name":134,"role":52,"phone":25,"phoneExt":25,"email":25},{"facility":139,"status":55,"city":140,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Zhejiang Cancer Hospital","Zhejiang",{"type":40,"coordinates":142},[143,144],105.583,25.3238,{"lat":144,"lon":143},[147,151],{"name":148,"role":29,"phone":149,"phoneExt":25,"email":150},"Linfa Li","+86 13666670158","pet-ct001@163.com",{"name":148,"role":52,"phone":25,"phoneExt":25,"email":25},{"type":153,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100573756","phase-3-89zr-tlx250-for-petct-imaging-of-ccrcc---zircon-cp-study-100573756",false,"NCT06750419","89Zr-TLX250 for PET\u002FCT Imaging of ccRCC - ZIRCON-CP Study","A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)","Inclusion Criteria:\n\n1. Written and voluntarily given informed consent.\n2. Mainland Chinese male or female, aged ≥ 18 years.\n3. Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.\n4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.\n5. Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.\n6. Sufficient life expectancy to justify nephrectomy.\n7. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.\n\nExclusion Criteria:\n\n1. A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.\n2. Renal mass known to be a metastasis of another primary tumour.\n3. Active non-renal malignancy requiring therapy during the time frame of the study participation.\n4. Multiple unilateral or bilateral IRM.\n5. Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (\\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0).\n6. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).\n7. Exposure to murine or chimeric antibodies within the last 5 years.\n8. Previous administration of any radionuclide within 10 half-lives of the same.\n9. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the study subject, as judged by the investigator.\n10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n11. Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.\n12. Women who are pregnant or breastfeeding.\n13. Known hypersensitivity to girentuximab or desferoxamine (DFO).\n14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL\u002Fmin\u002F1.73 m².\n15. Vulnerable patients (e.g., being in detention).","ALL","18 Years",{"count":164,"type":165},82,"ESTIMATED","INTERVENTIONAL",[168],"PHASE3","89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)",[171],"Clear Cell Renal Cell Carcinoma",[21,22,23,173,174,175,24,176],"Clear Cell Renal Cell Carcinoma (ccRCC)","Indeterminate Renal Mass (IRM)","ZIRCON-CP study","89Zr-TLX250","2024-12-19",{"date":179,"type":180},"2024-12-27","ACTUAL",{"date":182,"type":180},"2024-11-06",{"date":184,"type":165},"2026-06-30",{"name":5,"class":6},8]