The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.
The ZIRCON trial, which includes twelve participating clinical study sites across the U.S. and Canada, initiated patient recruitment in the U.S. on Friday, with the first patients being dosed with TLX250-CDx at University of California, Los Angeles (UCLA), and Seattle Cancer Care Alliance, University of Washington, Seattle (SCCA). The remaining seven U.S. sites2 and three sites3 in Canada are expected to commence patient recruitment progressively over the next month.
Telix Chief Medical Officer, Dr. Colin Hayward, stated, “We are pleased to have commenced the Phase III ZIRCON clinical trial in North America and wish to express our gratitude to Prof. Allan Pantuck and Dr. Delphine Chen, principal investigators at UCLA and SCCA, respectively, as well as their clinical research teams and patients, who have made this important milestone possible.”
About the ZIRCON Study
ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) is an international multi-centre Phase III study at 36 sites in Europe, Australia, Turkey, Canada, and the United States (subject to regulatory approval in the various jurisdictions). ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.
References:
- ClinicalTrials.Gov Identifier: NCT03849118.
- City of Hope, Duarte California; Advanced Molecular Imaging and Therapy, Maryland; Barbara Ann Karmanos Cancer Hospital, Detroit; Emory University, Atlanta Georgia; John Hopkins, Baltimore; Washington University, St Louis; Memorial Sloan Kettering, New York City.
- Sir Mortimer B. Davis Jewish General Hospital, Montreal; CHU de Québec-Université Laval, Quebec City; Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montreal.