Piotr Wysocki: [89Zr]Zr-girentuximab is highly sensitive and specific for clear-cell RCC imaging

Piotr Wysocki recently shared a post on LinkedIn:

“A phase 3 trial, ZIRCON, evaluated the use of the monoclonal antibody [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma (ccRCC). The [89Zr]Zr-girentuximab binds specifically to carbonic anhydrase 9 (CA9), a tumor antigen highly expressed in ccRCC.

The multinational ZIRCON trial was in nine countries and involved 332 enrolled patients. Participants had indeterminate renal masses measuring 7 cm or smaller and were scheduled for nephrectomy. Each patient received a single intravenous dose of [89Zr]Zr-girentuximab, followed by PET-CT imaging within five days. Histopathological diagnosis from surgery served as the reference standard for evaluating the sensitivity and specificity of the PET-CT results.

Key Findings

• Sensitivity and Specificity: The imaging technique showed a mean sensitivity of 85.5% and a mean specificity of 87.0% in detecting ccRCC. This indicates that [89Zr]Zr-girentuximab PET-CT was highly accurate in differentiating ccRCC from other renal masses.
• Safety Profile: The treatment was well tolerated, with no significant safety signals linked to [89Zr]Zr-girentuximab. Most adverse events occurred during or after surgery and were not related to the imaging agent.
• Adverse Events: The most common serious adverse events reported included post-procedural hemorrhage, urinary retention, and hypertension. Importantly, no treatment-related deaths were observed.

[89Zr]Zr-girentuximab PET-CT may significantly impact clinical decisions in ccRCC patients, maybe to a similar extent as 68Ga-PSMA-11 did in prostate cancer patients.”

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial

Authors: Brian Shuch, Allan J Pantuck, Jean-Christophe Bernhard, Michael A Morris, Viraj Master, Andrew M Scott, Charles van Praet, Clement Bailly, Bülent Önal, Tamer Aksoy, Robin Merkx, David M Schuster, Sze Ting Lee, Neeta Pandit-Taskar, Alice C Fan, Phillip Allman, Karl Schmidt, Libuse Tauchmanova, Michael Wheatcroft, Christian Behrenbruch, Colin R W Hayward and Peter Mulders.

Source: Piotr Wysocki/LinkedIn

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