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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

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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

https://clinicaltrials.gov/ct2/show/NCT05432947.

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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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Corresponding authors

Correspondence to Xinrong Fan, Lin Zhu, Hank F. Kung or Zhaohui Zhu.

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Ethical approval

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.

Consent to participate

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

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