From Metabolism to Molecular Phenotype: Carbonic Anhydrase IX-Targeted [⁶⁸Ga]Ga-DPI-4452 PET/CT in Renal Cell Carcinoma: A Prospective Multicenter Comparison with [¹⁸F]FDG PET/CT.

Authors

Halil Kömek, Esra Arslan, Canan Can, Elife Akgün, Rıdvan Kılıç, Uğur Yücetaş, Nadiye Akdeniz, Tevfik Fikret Çermik, Zuhat Urakçı, Tünkut Doğanca, Murat Bardakçı, Ömer Yeprem, Ali Rıza Kural

Published in

Journal of nuclear medicine : official publication, Society of Nuclear Medicine. Sep 17, 2026. Epub Sep 17, 2026.

Abstract

The objective of this study was to prospectively compare the diagnostic performance, lesion detection capability, and clinical staging impact of [⁶⁸Ga]Ga-DPI-4452 PET/CT with that of [¹⁸F]FDG PET/CT in renal cell carcinoma (RCC) using a multicenter design. Methods: Sixty-eight patients with RCC were prospectively enrolled, including patients with newly diagnosed primary tumors, patients under active surveillance or ongoing systemic treatment, and patients with suspected recurrent or metastatic disease. Both PET/CT scans were performed within the same week. The primary endpoint was patient-based diagnostic accuracy; secondary endpoints included lesion detection rate, SUV_max, maximum tumor-to-background ratio, clinical management impact, and adverse events. Results: The median age was 59.5 y; 52 patients (76.5%) were men. Overall diagnostic accuracy was 92.6% for [⁶⁸Ga]Ga-DPI-4452 PET/CT versus 80.9% for [¹⁸F]FDG PET/CT (P = 0.1435). In the clear cell RCC (ccRCC) subgroup (n = 56), accuracy was 98.2% versus 76.8%, respectively (P = 0.0034). [⁶⁸Ga]Ga-DPI-4452 detected 90.9% of all lesions (97.9% in ccRCC), compared with 56.7% (47.1% in ccRCC) for [¹⁸F]FDG. Median SUV_max was 19.7 versus 4.3, and median of the maximum tumor-to-background ratio was 19.8 versus 2.1 for [⁶⁸Ga]Ga-DPI-4452 versus [¹⁸F]FDG (both P < 0.001). In the ccRCC subgroup, [⁶⁸Ga]Ga-DPI-4452 led to clinical management changes in 21 patients (37.5%), compared with 1 patient (1.8%) for [¹⁸F]FDG. No adverse events were observed. Conclusion: [⁶⁸Ga]Ga-DPI-4452 PET/CT provides superior lesion detection, tumor-to-background contrast, and diagnostic accuracy compared with [¹⁸F]FDG PET/CT in ccRCC, reflecting direct visualization and targeting of the von Hippel-Lindau, hypoxia-inducible factor, and carbonic anhydrase IX axis. With its rapid pharmacokinetic profile and theranostic potential, [⁶⁸Ga]Ga-DPI-4452 may represent a new molecular imaging standard in ccRCC.

PMID:
42754347
Bibliographic data and abstract were imported from PubMed on 18 Sep 2026.

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