Clinical trial · Interventional
89Zr-TLX250 for PET/CT 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/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)
NCT06750419CI-TRIAL-00084130recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-TLX250 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm receiving the IP
- description
- Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT 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/CT imaging. Following 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. On 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/CT 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/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250.
- interventionNames
- Drug: 89Zr-TLX250 PET/CT
Primary outcomes (1)
- measure
- To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written and voluntarily given informed consent. 2. Mainland Chinese male or female, aged ≥ 18 years. 3. 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. 4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration. 5. 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. 6. Sufficient life expectancy to justify nephrectomy. 7. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration. Exclusion Criteria: 1. A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM. 2. Renal mass known to be a metastasis of another primary tumour. 3. Active non-renal malignancy requiring therapy during the time frame of the study participation. 4. Multiple unilateral or bilateral IRM. 5. 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). 6. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging). 7. Exposure to murine or chimeric antibodies within the last 5 years. 8. Previous administration of any radionuclide within 10 half-lives of the same. 9. 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. 10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 11. 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. 12. Women who are pregnant or breastfeeding. 13. Known hypersensitivity to girentuximab or desferoxamine (DFO). 14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m². 15. Vulnerable patients (e.g., being in detention).
References
Publications (44)
- BACKGROUNDShuch B, Pantuck AJ, Bernhard JC, Morris MA, Master V, Scott AM, van Praet C, Bailly C, Onal B, Aksoy T, Merkx R, Schuster DM, Lee ST, Pandit-Taskar N, Fan AC, Allman P, Schmidt K, Tauchmanova L, Wheatcroft M, Behrenbruch C, Hayward CRW, Mulders P. [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Oct;25(10):1277-1287. doi: 10.1016/S1470-2045(24)00402-9. Epub 2024 Sep 10. PMID 39270701
- BACKGROUND2010 年第 7 版肾癌新分期的应用效果评估
- BACKGROUND肾包膜侵犯状况对于 肾癌临床症状及分期的意义
- BACKGROUNDZIRDOSE. An open-label, Phase I study to assess safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labelled girentuximab (89Zr-girentuximab) for in vivo detection of clear cell renal carcinoma (CCRC) by positron emission tomography (PET) using different PET imaging methodologies. ClinicalTrials.gov: NCT03556046
- BACKGROUNDZIRDAC-JP. Phase 1 open-label study to evaluate the safety/tolerability/radioactivity distribution of positron emission tomography (PET/CT) imaging with 89Zr-girentuximab (89Zr-TLX250) as well as to investigate its pharmacokinetics and pharmacodynamics in subjects with renal cell carcinoma including clear cell renal cell carcinoma (ZIRDAC-JP). ClinicalTrials.gov : NCT04496089
- BACKGROUNDZIRCON. A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study). ClinicalTrials.gov: NCT03849118
- BACKGROUNDWang HY, Ding HJ, Chen JH, Chao CH, Lu YY, Lin WY, Kao CH. Meta-analysis of the diagnostic performance of [18F]FDG-PET and PET/CT in renal cell carcinoma. Cancer Imaging. 2012 Oct 26;12(3):464-74. doi: 10.1102/1470-7330.2012.0042. PMID 23108238
- BACKGROUNDvan Asselt SJ, Oosting SF, Brouwers AH, Bongaerts AH, de Jong JR, Lub-de Hooge MN, Oude Munnink TH, Fiebrich HB, Sluiter WJ, Links TP, Walenkamp AM, de Vries EG. Everolimus Reduces (89)Zr-Bevacizumab Tumor Uptake in Patients with Neuroendocrine Tumors. J Nucl Med. 2014 Jul;55(7):1087-92. doi: 10.2967/jnumed.113.129056. Epub 2014 May 1.