Abstract
Purpose
This pilot study was prospectively designed to evaluate and compare the diagnostic value of PET/CT using a PSMA-specific tracer [68Ga]Ga-P16-093 and a glucose metabolism probe 2-[18F]FDG in clear cell renal cell carcinoma (ccRCC) patients.
Methods
Forty-two pathologically confirmed ccRCC patients were included. Within 1 week, each patient underwent [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT. In addition to visual analysis of tumor number, the standardized uptake value (SUV) was measured for semiquantitative comparison and correlation analysis.
Results
For primary ccRCC patients, [68Ga]Ga-P16-093 PET/CT demonstrated a significantly higher detection rate (19/22 vs. 13/22, P = 0.031) and higher tumor uptake (15.7 ± 9.0 vs. 5.1 ± 3.4, P < 0.001) than 2-[18F]FDG PET/CT. In addition, the SUVmax of the primary tumor on [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT was significantly correlated with pT stage (for [68Ga]Ga-P16-093, r = 0.550, P = 0.008; for 2-[18F]FDG, r = 0.514, P = 0.014) and WHO/ISUP grade (for [68Ga]Ga-P16-093, r = 0.566, P = 0.006; for 2-[18F]FDG, r = 0.492, P = 0.020), respectively. For metastatic ccRCC patients, [68Ga]Ga-P16-093 PET/CT also demonstrated a better detection rate (21/22 vs. 14/22, P = 0.008) and higher tumor uptake (11.0 ± 6.4 vs. 4.4 ± 2.7, P < 0.001) than 2-[18F]FDG PET/CT. The SUVmax on [68Ga]Ga-P16-093 PET/CT had a significant association with PSMA expression in primary ccRCC (r = 0.776, P < 0.001) and metastatic ccRCC (r = 0.626, P = 0.029).
Conclusions
[68Ga]Ga-P16-093 PET/CT demonstrates significantly better tumor detectability than 2-[18F]FDG PET/CT for ccRCC patients.
Trial registration
68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients (NCT05432947, Registered 27 June 2021, retrospectively registered)
URL of registry
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Data availability
Not applicable
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Funding
This study was supported by the Fundamental Research Funds for the Central Universities (3332022110), the National High Level Hospital Clinical Research Funding (2022-PUMCH-C-002), Chinese Academy of Medical Science Innovation Fund for Medical Sciences (2022-I2M-C&T-A-008, 2022-I2M-2–002, 2021-I2M-1–016), Beijing Natural Science Foundation (M22035), and the National Natural Science Foundation of China (82272046, 81871392).
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Ethical approval was obtained from the Institute Review Board of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (no. ZS-2532), and this study was conducted in accordance with the principles of the Declaration of Helsinki.
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Informed consent was obtained from all participants included in the study.
Conflict of interest
Hank F. Kung is the founder of Five Eleven Pharma, which holds the patent rights for [68Ga]Ga-P16-093 and related technology. Other authors have no conflicts of interest or relevant financial activities to disclose.
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Wang, G., Li, L., Wang, J. et al. Head-to-head comparison of [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT in patients with clear cell renal cell carcinoma: a pilot study. Eur J Nucl Med Mol Imaging 50, 1499–1509 (2023). https://doi.org/10.1007/s00259-022-06101-3
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DOI: https://doi.org/10.1007/s00259-022-06101-3