Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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)

89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study (NCT06750419) is a Phase 3 interventional studying Clear Cell Renal Cell Carcinoma, sponsored by Telix Pharmaceuticals (Innovations) Pty Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Clear Cell Renal Cell Carcinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 82 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Clear Cell Renal Cell Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written and voluntarily given willing to sign a consent form. 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

89Zr-TLX250 PET/CT

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/mol. 89Zr-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.

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Cancer Hospital

Beijing, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Hubei, China

Zhongshan Hospital, Fudan University

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Affiliated Hospital Of Jiangnan University

Wuxi, China

Zhejiang Cancer Hospital

Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06750419), the sponsor (Telix Pharmaceuticals (Innovations) Pty Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06750419 clinical trial studying?

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) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06750419?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06750419?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06750419. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06750419. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.