{"id":21584,"date":"2024-09-10T23:37:31","date_gmt":"2024-09-10T23:37:31","guid":{"rendered":"https:\/\/allonlinebanglanewspapers.com\/news\/highly-accurate-telixs-phase-iii-zircon-trial-for-kidney-cancer-imaging-published-in-the-lancet-oncology\/"},"modified":"2024-09-10T23:37:31","modified_gmt":"2024-09-10T23:37:31","slug":"highly-accurate-telixs-phase-iii-zircon-trial-for-kidney-cancer-imaging-published-in-the-lancet-oncology","status":"publish","type":"post","link":"https:\/\/allonlinebanglanewspapers.com\/news\/highly-accurate-telixs-phase-iii-zircon-trial-for-kidney-cancer-imaging-published-in-the-lancet-oncology\/","title":{"rendered":"\u2018Highly Accurate\u2019: Telix\u2019s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology"},"content":{"rendered":"
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MELBOURNE, Australia, Sept. 11, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON1<\/sup> trial have been published in The Lancet Oncology, <\/em>reporting that Telix\u2019s first-in-class investigational PET2<\/sup> agent, TLX250-CDx (Zircaix\u00ae3<\/sup>, 89<\/sup>Zr-girentuximab), is highly accurate in detecting and characterizing clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).<\/p>\n

In this peer-reviewed manuscript, Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues report results from this prospective, open-label, multicentre, Phase III trial in which 300 patients with an IRM \u22647cm (cT1) received TLX250-CDx. Authors conclude that TLX250-CDx \u201chas a favorable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterization of ccRCC, which has the potential to be practice changing.\u201d<\/p>\n

Authors explain that small masses in the kidney are increasingly being detected incidentally when patients undergo abdominal imaging, often for other health conditions, contributing to \u201can era of gross overtreatment\u201d. Diagnosis and treatment are limited by current imaging techniques, and renal mass biopsy is invasive, which can often lead to complications. Up to 30% of patients undergo unnecessary surgery, removing masses that are later determined to be benign4<\/sup>. If confirmed, however, ccRCC is the most common and aggressive form of kidney cancer, and delays in diagnosis can significantly reduce survival rates.<\/p>\n

Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and a ZIRCON principal investigator, said, \u201cUntil now, assessing whether renal masses are cancerous has been difficult and often involves invasive surgery or percutaneous biopsy. This is because standard imaging technology \u2013 either a CT or MRI scan \u2013 cannot reliably differentiate between benign or malignant renal lesions or provide information about disease biology.<\/p>\n

\u201cThe challenges and uncertainty in diagnosing ccRCC underscore a critical unmet need for a new, non-invasive technique that accurately detects and differentiates ccRCC from other renal masses in patients, to inform clinical decision making. The ZIRCON trial has shown that TLX250-CDx is a breakthrough technology that can address this need.\u201d<\/p>\n

TLX250-CDx is a zirconium-89 (89<\/sup>Zr) radiolabelled monoclonal antibody that targets carbonic anhydrase IX (CAIX), a tumor-associated antigen highly expressed in ccRCC. Following successful Phase I and II trials to establish safety and preliminary efficacy, the ZIRCON trial was designed to assess sensitivity and specificity of TLX250-CDx PET\/CT imaging to non-invasively detect ccRCC in patients with cT1 IRMs (\u22647 cm in diameter) who underwent nephrectomy, using central histological confirmation as standard of truth.<\/p>\n

Key findings of the ZIRCON trial, outlined in the paper, include:<\/strong><\/p>\n