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ZIRCON Phase III Study: [89Zr]Zr-girentuximab for PET/CT Imaging of ccRCC

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Reno, Nevada (UroToday.com) --Telix welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix’s investigational PET1 agent, TLX250-CDx (Zircaix®,2 89Zr-DFO-girentuximab), for molecular imaging of renal masses.
Renal cell carcinoma (RCC), particularly clear cell RCC (ccRCC), remains a significant clinical challenge due to the limitations of conventional imaging techniques in distinguishing malignant from benign small renal masses (SRMs). Early and accurate diagnosis is critical, as localized ccRCC boasts a five-year survival rate exceeding 90%, while metastatic disease sees survival rates plummet to just 12%. In this context, novel imaging approaches are urgently needed to refine diagnostic accuracy and guide patient management.
Reno, Nevada (UroToday.com) -- Telix announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix®,2 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27 August 2025, paving the way for a U.S. commercial launch in 2025.
Background: With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. 89Zr-labelled monoclonal antibody ([89Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [89Zr]Zr-girentuximab PET–CT imaging for detection and characterisation of clear-cell renal cell carcinoma.
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Irene Huebner-Resch, MD
The European Association of Urology (EAU) 2026 Annual Congress was host to a renal cell carcinoma abstract session. Dr. Huebner-Resch presented her team’s initial real-world experience using [89Zr]Zr-girentuximab PET/CT in the routine evaluation of patients with indeterminate renal masses.
Presented by David Liu, MD
The European Association of Urology (EAU) 2026 Annual Congress was host to a renal cell carcinoma abstract session. Dr. David Liu presented results from ZIRCON-X, a post-hoc analysis of the phase 3 ZIRCON study evaluating the potential impact of 89Zr-girentuximab PET imaging on clinical management decisions for patients presenting with indeterminate renal masses (IRMs).
Presented by Brian Shuch, MD
The 2025 SUO annual meeting featured a kidney session and a presentation by Dr. Brian Shuch discussing ZIRCON-X and the impact of 89Zr-girentuximab PET/CT versus conventional imaging on clinical decision-making in patients with indeterminate renal masses. Current standard of care for the detection of clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses is based on conventional imaging with contrast-enhanced CT/MRI and renal mass biopsy.
Presented by Shadi Esfahani, MD & Timothy McClure, MD
The 2025 SNMMI annual meeting featured a kidney cancer session and a presentation by Drs. Shadi Esfahani and Timothy McClure discussing CAIX-PET imaging and the shift toward precision diagnostics in kidney cancer.
Presented by Darren R. Feldman, MD
Darren R. Feldman, MD, presented the trial in progress Poster TPS4612: STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma (ccRCC).
Presented by Pratik Kanabur, MD
The 2025 AUA annual meeting featured a kidney cancer session and a presentation by Dr. Pratik Kanabur discussing a cost-effectiveness analysis of 89Zr-girentuximab PET-CT (TLX250) to guide management of small renal masses. With the limitations of conventional imaging and biopsy, accurate and non-invasive techniques to characterize small renal masses remain an unmet need. The ZIRCON trial demonstrated that TLX250 PET/CT scans aid in small renal masses characterization.
Presented by Brian Shuch, MD
The 2025 PSMA and Beyond annual meeting featured a new developments in genitourinary radioligand therapy session and a presentation by Dr. Brian Shuch discussing CA-IX in renal cell cancer (RCC). Secondary to 43% of Medicare patients having a CT of the chest/abdomen within 5 years, this has led to an increase in detection of 2-4 cm tumors.
Presented by Teresa Alonso Gordoa, MD
The 2024 ESMO Annual Congress was host to the session Updates in the management of advanced renal cell carcinoma. Dr. Teresa Alonso Gordoa discussed systemic treatment options for the management of advanced renal cell carcinoma.
Presented by Peter Mulders, MD, PhD
The 2024 EAU annual congress was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professor Peter Mulders discussed why molecular imaging evaluation is the ‘way to go’ for the initial staging of renal cell cancer.
Presented by Marc Bjurlin, DO, MSc, FACOS
The 2024 SESAUA annual meeting featured an AUA Course Lecture and a presentation by Dr. Marc Bjurlin discussing current approaches and future opportunities for integrating molecular imaging into urologic oncology clinical practice. 
Presented by Jeremie Calais, MD, MSc
Jeremie Calais presented the results of the ZIRCON phase 3 trial that evaluated the test performance characteristics of 89Zr-DFO-girentuximab PET/CT imaging for the accurate detection of clear cell RCC primary and secondary lesions in patients with renal masses detected via conventional imaging.
Presented by Jeremie Calais, MD, MSc
The 2023 SNMMI Annual Meeting was host to a session on urologic malignancies. Following his earlier presentation of the ZIRCON phase 3 study results in the overall cohort, Dr. Calais next presented results from the UCLA cohort of this trial.
Presented by Maria Carmen Mir, MD, PhD, FEBU
 The 2023 EAU annual congress was host to a game changing session. Dr. Maria Carmen Mir led the discussant session following Professor Peter Mulders’ earlier presentation of the phase 3 ZIRCON trial results.
Presented by Peter Mulders, MD, PhD
The 2023 EAU annual congress was host to a game changing session. Professor Peter Mulders presented results from the phase 3 ZIRCON study, which evaluated 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma.
Presented by Brian M. Shuch, MD
 The 2023 GU ASCO annual meeting included an oral abstract session on renal cell carcinoma (RCC), featuring a presentation by Dr. Brian Shuch discussing results from ZIRCON, a phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell RCC.