LBA03-01 89 Zr-DFO-GIRENTUXIMAB FOR PET/CT IMAGING OF INDETERMINATE RENAL MASSES–RESULTS FROM PHASE 3 ZIRCON STUDY

You have accessJournal of UrologyCME1 Apr 2023LBA03-01 89Zr-DFO-GIRENTUXIMAB FOR PET/CT IMAGING OF INDETERMINATE RENAL MASSES–RESULTS FROM PHASE 3 ZIRCON STUDY Brian Shuch, Allan J. Pantuck, Jean-Christophe Bernhard, Michael A. Morris, Viraj Master, Andrew Scott, Charles van Praet, Clement Bailly, Bülent Önal, Tamer Aksoy, Robin Merkx, David M. Schuster, Sze Ting Lee, Neeta Pandit-Taskar, Alice C. Fan, Libuse Tauchmanova, Karl Schmidt, Kavita Vadali, Colin Hayward, and Peter Mulders Brian ShuchBrian Shuch More articles by this author , Allan J. PantuckAllan J. Pantuck More articles by this author , Jean-Christophe BernhardJean-Christophe Bernhard More articles by this author , Michael A. MorrisMichael A. Morris More articles by this author , Viraj MasterViraj Master More articles by this author , Andrew ScottAndrew Scott More articles by this author , Charles van PraetCharles van Praet More articles by this author , Clement BaillyClement Bailly More articles by this author , Bülent ÖnalBülent Önal More articles by this author , Tamer AksoyTamer Aksoy More articles by this author , Robin MerkxRobin Merkx More articles by this author , David M. SchusterDavid M. Schuster More articles by this author , Sze Ting LeeSze Ting Lee More articles by this author , Neeta Pandit-TaskarNeeta Pandit-Taskar More articles by this author , Alice C. FanAlice C. Fan More articles by this author , Libuse TauchmanovaLibuse Tauchmanova More articles by this author , Karl SchmidtKarl Schmidt More articles by this author , Kavita VadaliKavita Vadali More articles by this author , Colin HaywardColin Hayward More articles by this author , and Peter MuldersPeter Mulders More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003426.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The increasing detection of renal masses (RM) presents a significant dilemma as conventional tools (eg, CT, MRI, biopsy) have limitations. Approximately 25% of patients with RM <4 cm undergo unnecessary surgery. Accurate noninvasive techniques to risk stratify patients with RM remains an unmet need. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), an enzyme highly expressed in clear cell renal carcinoma (ccRCC). Radiolabeled 89Zr-DFO-girentuximab can aid differentiation between ccRCCs and other renal lesions. ZIRCON (NCT03849118) evaluated the performance of 89Zr-DFO-girentuximab PET/CT for detection of ccRCC in patients with indeterminate RM (IDRM). METHODS: In this open label trial, patients with an IDRM (≤7 cm; stage cT1), scheduled for partial or radical nephrectomy within 90 days from planned 89Zr-DFO-girentuximab dosing, were eligible. Enrolled patients received a single dose IV (37 MBq±10%; 10 mg girentuximab) on Day 0 and underwent abdominal PET/CT on Day 5 (±2 d). Blinded central histology review determined ccRCC status. Coprimary objectives were to evaluate both the sensitivity and specificity of TLX250-CDx PET/CT imaging in detecting ccRCC in patients with IDRM, using histology as standard of truth. Key secondary objectives included sensitivity and specificity of 89Zr-DFO-girentuximab PET/CT in patients with IDRM ≤4cm (cT1a). Other objectives included assessment of safety and tolerability, and suspected secondary lesions; the latter was investigated as per institutional protocols. RESULTS: 300 patients (mean age 62±12 y; 71% Male) received 89Zr-DFO-girentuximab. Of 288 patients with central histopathology assessment, 67% had ccRCC, and 62% had CT1a masses. The primary analysis included 284 patients. Across all 3 readers, average [95% CI] sensitivity and specificity was 86% [80%, 90%] and 87% [79%, 92%] respectively for coprimary endpoints, and 85% [77%, 91%] and 90% [79%, 95%] respectively for key secondary. Of 11 PET+ patients who were ccRCC− on central histopathology, 9 had papillary RCC, and 1 each had sarcoma and oncocytoma. Renal masses were classified as Bosniak I, II, IIF, III, and IV in 7 (2.5%), 9 (3.2%), 8 (2.8%), 65 (22.9%), and 192 (67.6%) patients, respectively. Of 263 adverse events (AEs) in 124 patients, 2 treatment-related AEs of mild intensity were reported. CONCLUSIONS: 89Zr-DFO-girentuximab PET/CT is well tolerated and can accurately and noninvasively identify and characterize IDRMs, showing promising utility for guiding surgical and treatment decisions. Source of Funding: Telix Pharmaceuticals © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1192 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Brian Shuch More articles by this author Allan J. Pantuck More articles by this author Jean-Christophe Bernhard More articles by this author Michael A. Morris More articles by this author Viraj Master More articles by this author Andrew Scott More articles by this author Charles van Praet More articles by this author Clement Bailly More articles by this author Bülent Önal More articles by this author Tamer Aksoy More articles by this author Robin Merkx More articles by this author David M. Schuster More articles by this author Sze Ting Lee More articles by this author Neeta Pandit-Taskar More articles by this author Alice C. Fan More articles by this author Libuse Tauchmanova More articles by this author Karl Schmidt More articles by this author Kavita Vadali More articles by this author Colin Hayward More articles by this author Peter Mulders More articles by this author Expand All Advertisement PDF downloadLoading ...