Lay Title: Telix ZIRCON: A study to determine the ability of the administered ZIRCON to correctly identify your kidney cancer in PET scans
Technical Title: A confirmatory, prospective, open-label, multi-center phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect ccRCC by PET/CT imaging in patients with indeterminate renal masses
Disease Type: Patients must have a scan showing a single indeterminate kidney mass, ≤7 cm in the largest diameter. They must also be scheduled for surgery to remove the kidney mass.
With current imaging techniques, it can sometimes be difficult to tell if a kidney mass is cancer or benign (non-cancerous). This research study will test a new imaging agent called 89Zr-TLX250. Imaging agents show brightness/contrast on scans in areas where tumors/masses may be present. 89Zr-TLX250 has combined the radionuclide (radioactive molecule) known as zirconium-89, with the antibody girentuximab (a protein made in a lab), that is known to specifically bind to clear cell renal cell carcinoma (ccRCC). It is thought that 89Zr-TLX250 will bind to ccRCC cells and appear ‘brighter’ on the PET/CT scan than normal cells.
The aim of this study is to determine the ability of 89Zr-TLX250 to correctly identify the nature of the known or suspected cancer within your kidney. If the study is successful, it can change how kidney masses are managed by preventing unnecessary biopsies or surgery if the growth is benign.
Research Procedures (not a complete list):
You will come to clinic for a screening visit to determine if you qualify for the study. If you qualify, you will attend 3 to 4 visits. During the first visit, you will receive an injection of 89Zr-TLX250. A few days later, you will return for a PET/CT scan. Depending on the timing of your kidney surgery, you will return for another 1 to 2 visits after your kidney surgery to complete safety assessments.
Eligibility Criteria (Not a complete list):
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