[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573756":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":45,"overallOfficials":30,"centralContacts":56,"locations":62,"responsibleParty":182,"collaborators":30,"id":184,"slug":30,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":30,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":30,"enrollmentInfo":192,"targetDuration":30,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the sensitivity and specificity of qualitative assessment of PET\u002FCT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth","Evaluating this outcome involved using a PET\u002FCT machine on all patients to determine the uptake of the Zr89 radiotracer within the renal lesion, which was then compared to the histological determination of the lesion type following resection","From Visit 4 till end of study. Diagnostic PET\u002FCT scan on Day 5±2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth",[14,18,21,23,27],{"measure":15,"description":16,"timeFrame":17},"To determine the 89Zr-TLX250's test performance","Determine the Standardized Uptake Value (SUV) in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.","Day of Imaging (Day 5±2 post- IP administration).",{"measure":15,"description":19,"timeFrame":20},"Determine the predictive values (%) of 89Zr-TLX250 PET\u002FCT in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.","Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).",{"measure":15,"description":22,"timeFrame":20},"Evaluate the diagnostic accuracy (%) of 89Zr-TLX250 PET\u002FCT in distinguishing ccRCC from non-ccRCC in the kidney in the Chinese patient population.",{"measure":24,"description":25,"timeFrame":26},"To assess the safety and tolerability of 89Zr-TLX250","Number of AEs, incidence of anti-drug antibody detection following use of the study drug in Chinese patients with IRM","Day of IP administration (Day 0), Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28-90 days post-IP administration)",{"measure":28,"description":29,"timeFrame":20},"To evaluate the impact of 89Zr-TLX250 PET\u002FCT on clinical decision-making as a diagnostic tool","Proportion of participants with changes in management plans based on PET\u002FCT scan findings versus conventional imaging following the use of 89Zr-TLX250",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care.\n\nApproximately 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\nThe study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial\u002Ftotal nephrectomy will then be performed at institutional discretion any time following the PET\u002FCT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.\n\nOn Day 5±2 post study drug administration, an abdominal PET\u002FCT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET\u002FCT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator.\n\nImage data analyses will be performed by a central imaging vendor.\n\nFor participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery.\n\nImage data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging \\[MRI\\]), will be used to assess test performance or 89Zr-TLX-250 PET\u002FCT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.\n\nThe duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months.\n\nNo interim analysis is planned for this study.",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44],"Drug: 89Zr-TLX250 PET\u002FCT",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"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.",[40],[52,53,54,55],"89Zr-DFO-girentuximab","89Zr-girentuximab","89Zr-DFO-TFP-GTX","89Zirconium-labelled girentuximab",[57],{"name":58,"role":59,"phone":60,"phoneExt":30,"email":61},"Lily Nahidi","CONTACT","+61 3909 33871","lily.nahidi@telixpharma.com",[63,83,98,112,126,140,154,168],{"facility":64,"status":65,"city":66,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Beijing Cancer Hospital","RECRUITING","Beijing","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76,80],{"name":77,"role":59,"phone":78,"phoneExt":30,"email":79},"Peng Du","+86 13611376873","dupeng9000@126.com",{"name":81,"role":82,"phone":30,"phoneExt":30,"email":30},"Peng Du, Prof","PRINCIPAL_INVESTIGATOR",{"facility":84,"status":85,"city":86,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Zhejiang Provincial People's Hospital","NOT_YET_RECRUITING","Hangzhou",{"type":70,"coordinates":88},[89,90],120.16142,30.29365,{"lat":90,"lon":89},[93,97],{"name":94,"role":59,"phone":95,"phoneExt":30,"email":96},"Xiaolong Qi","+86 15158885167","15158885167@163.com",{"name":94,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":99,"status":85,"city":100,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Union Hospital Tongji Medical College Huazhong University Of Science And Technology","Hubei",{"type":70,"coordinates":102},[103,104],120.41732,29.08114,{"lat":104,"lon":103},[107,111],{"name":108,"role":59,"phone":109,"phoneExt":30,"email":110},"Xiaoli Lan","+86 13886193262","HZSLXL@163.com",{"name":108,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":113,"status":85,"city":114,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Zhongshan Hospital, Fudan University","Shanghai",{"type":70,"coordinates":116},[117,118],121.45806,31.22222,{"lat":118,"lon":117},[121,125],{"name":122,"role":59,"phone":123,"phoneExt":30,"email":124},"Hongcheng Shi","+86 13681971579","shi.hongcheng@zs-hospital.sh.cn",{"name":122,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":127,"status":85,"city":128,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The First Affiliated Hospital of Soochow University","Suzhou",{"type":70,"coordinates":130},[131,132],120.59538,31.30408,{"lat":132,"lon":131},[135,139],{"name":136,"role":59,"phone":137,"phoneExt":30,"email":138},"Shibiao Sang","+86 13962112507","golf131701@sina.com",{"name":136,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":141,"status":85,"city":142,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Tianjin Cancer Hospital Airport Hospital","Tianjin",{"type":70,"coordinates":144},[145,146],117.17667,39.14222,{"lat":146,"lon":145},[149,153],{"name":150,"role":59,"phone":151,"phoneExt":30,"email":152},"Dong Dai","+86 18622000577","xiandao5502@163.com",{"name":150,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":155,"status":85,"city":156,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Affiliated Hospital Of Jiangnan University","Wuxi",{"type":70,"coordinates":158},[159,160],120.28857,31.56887,{"lat":160,"lon":159},[163,167],{"name":164,"role":59,"phone":165,"phoneExt":30,"email":166},"Chunjing Yu","+86 15312238622","ycj_wxd1978@163.com",{"name":164,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":169,"status":85,"city":170,"state":30,"zip":30,"country":67,"countryCode":68,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Zhejiang Cancer Hospital","Zhejiang",{"type":70,"coordinates":172},[173,174],105.583,25.3238,{"lat":174,"lon":173},[177,181],{"name":178,"role":59,"phone":179,"phoneExt":30,"email":180},"Linfa Li","+86 13666670158","pet-ct001@163.com",{"name":178,"role":82,"phone":30,"phoneExt":30,"email":30},{"type":183,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":193,"type":194},82,"ESTIMATED","INTERVENTIONAL",[197],"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)",[200],"Clear Cell Renal Cell Carcinoma",[52,53,54,202,203,204,55,205],"Clear Cell Renal Cell Carcinoma (ccRCC)","Indeterminate Renal Mass (IRM)","ZIRCON-CP study","89Zr-TLX250","2024-12-19",{"date":208,"type":209},"2024-12-27","ACTUAL",{"date":211,"type":209},"2024-11-06",{"date":213,"type":194},"2026-06-30",{"name":5,"class":6},8]