RecruitingPhase 3NCT06750419

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)

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

82 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Clear Cell Renal Cell Carcinoma

Summary

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special imaging agent called 89Zr-TLX250 used in a PET/CT scan to identify whether a kidney tumor is clear cell renal cell carcinoma (ccRCC) — the most common type of kidney cancer. This imaging method may help doctors diagnose the cancer type before surgery, avoiding the need for a separate biopsy in some cases. **You may be eligible if...** - You are 18 or older and a mainland Chinese resident - Imaging has identified a single kidney mass up to 7cm, classified as clinical stage T1 - You are scheduled for surgical removal of the kidney mass within 90 days - You have a negative pregnancy test (if applicable) before receiving the imaging agent **You may NOT be eligible if...** - You have more than one kidney mass - Your kidney mass is larger than 7cm - You have already had another biopsy or treatment for the mass - You are pregnant or unable to use effective contraception - Your life expectancy is too short to justify kidney surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG89Zr-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.