Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet Oncology, 25(10), 1277–1287. https://doi.org/10.1016/S1470-2045(24)00402-9 Dr. Brian Shuch et al.
Points
- This phase 3 study evaluated the efficacy of [89Zr]Zr-girentuximab PET-CT for detecting clear-cell renal cell carcinoma (ccRCC) in patients with 7 cm or smaller renal masses.
- The trial included 284 patients from 36 centers in nine countries. PET-CT imaging was performed within five days of receiving [89Zr]Zr-girentuximab.
- The imaging modality showed a mean sensitivity of 85.5% and specificity of 87.0%, demonstrating strong accuracy in distinguishing ccRCC from other renal masses.
- No significant safety concerns were identified, and most adverse events were related to surgery rather than the imaging agent; common grade 3 or higher events included hemorrhage (2%), urinary retention (1%), and hypertension (1%).
- [89Zr]Zr-girentuximab PET-CT demonstrated a favorable safety profile and diagnostic accuracy, suggesting it could become a non-invasive, practice-changing tool for managing renal masses and reducing the need for invasive procedures.
Summary
This phase 3 study assessed the efficacy of [89Zr]Zr-girentuximab PET-CT as a non-invasive imaging modality for detecting clear-cell renal cell carcinoma (ccRCC) in patients with renal masses. The trial, conducted across 36 centers in nine countries, included patients aged 18 years or older with indeterminate renal masses of 7 cm or more minor (cT1) scheduled for nephrectomy. Patients received a single intravenous dose of [89Zr]Zr-girentuximab followed by PET-CT imaging within five days. The coprimary endpoints were the sensitivity and specificity of this imaging technique, determined against histopathological findings.
A total of 284 evaluable patients were included in the primary analysis. The mean sensitivity of [89Zr]Zr-girentuximab PET-CT to detect ccRCC was 85.5% (95% CI: 81.5–89.6), and the mean specificity was 87.0% (95% CI: 81.0–93.1). The imaging approach showed substantial accuracy in distinguishing ccRCC, suggesting it may be a reliable, non-invasive alternative to conventional diagnostic methods. Importantly, no significant safety concerns were identified, and most adverse events were related to surgical procedures rather than the imaging agent itself. The most common grade 3 or higher adverse events included post-procedural hemorrhage (2%), urinary retention (1%), and hypertension (1%).
Overall, [89Zr]Zr-girentuximab PET-CT demonstrated a favorable safety profile and diagnostic solid performance, providing accurate non-invasive detection and characterization of ccRCC. The findings indicate that this imaging modality could significantly improve the diagnostic pathway for patients with suspected renal cell carcinoma, reducing the need for invasive procedures while maintaining diagnostic accuracy. This approach has the potential to become a practice-changing tool in the management of renal masses.
Link to the article: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00402-9/fulltext
References Shuch, B., Pantuck, A. J., Bernhard, J.-C., Morris, M. A., Master, V., Scott, A. M., Van Praet, C., Bailly, C., Önal, B., Aksoy, T., Merkx, R., Schuster, D. M., Lee, S. T., Pandit-Taskar, N., Fan, A. C., Allman, P., Schmidt, K., Tauchmanova, L., Wheatcroft, M., … Mulders, P. (2024). [89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: A prospective, open-label, multicentre, phase 3 trial. The Lancet Oncology, 25(10), 1277–1287. https://doi.org/10.1016/S1470-2045(24)00402-9
