Abstract
Purpose
This study was prospectively designed to evaluate the early dynamic organ distribution and tumor detection capability of [68 Ga]Ga-P16-093, which was compared with [68 Ga]Ga-PSMA-617 in the same group of recurrent prostate cancer patients.
Methods
Twenty patients with recurrent prostate cancer were enrolled. In 2 consecutive days, each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of 148–185 MBq (4–5 mCi) [68 Ga]Ga-P16-093 and [68 Ga]Ga-PSMA-617, respectively. Following a low-dose CT scan, serial dynamic PET scans were performed from head to proximal thigh at 9 time points (30 s/bed at 4, 7, 10, 13, and 16 min; 1 min/bed at 20, 30, and 45 min; and 2 min/bed at 60 min). Standardized uptake values were measured for semi-quantitative comparison.
Results
[68 Ga]Ga-P16-093 PET/CT revealed a significantly higher tumor uptake at 4 min (SUVmax 7.88 ± 5.26 vs. 6.01 ± 3.88, P < 0.001), less blood pool retention at 4 min (SUVmean 5.12 ± 1.16 vs. 6.14 ± 0.98, P < 0.001), and lower bladder accumulation at 60 min (SUVmean 31.33 ± 27.47 vs. 48.74 ± 34.01, P = 0.042) than [68 Ga]Ga-PSMA-617 scan. Significantly higher [68 Ga]Ga-P16-093 uptakes were also observed in the parotid gland, liver, spleen, and kidney. Besides, [68 Ga]Ga-P16-093 exhibited a better detectability of tumor than [68 Ga]Ga-PSMA-617 (366 vs. 321, P = 0.009).
Conclusions
[68 Ga]Ga-P16-093 showed advantages over [68 Ga]Ga-PSMA-617 with higher tumor uptakes, tumor-to-blood pool ratio and detection capability, less blood pool, and bladder accumulation in recurrent prostate cancer patients.
Trial registration: [68 Ga]Ga-P16-093 and [68 Ga]Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients (NCT04796467, Registered 12 March 2021, retrospectively registered)
URL of registry: https://clinicaltrials.gov/ct2/show/NCT04796467
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Data availability
Not applicable.
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Funding
This study was supported by the Chinese Academy of Medical Science Innovation Fund for Medical Sciences (2019-I2M-1–001), the Chinese Academy of Medical Science Clinical and Translational Medicine Research Foundation (2019XK320032), the National Natural Science Foundation of China (81871392), and the Capital Health Development Scientific Research Project (2018–1-4011).
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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, 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 [68 Ga]Ga-P16-093 and related technology.
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Wang, G., Hong, H., Zang, J. et al. Head-to-head comparison of [68 Ga]Ga-P16-093 and [68 Ga]Ga-PSMA-617 in dynamic PET/CT evaluation of the same group of recurrent prostate cancer patients. Eur J Nucl Med Mol Imaging 49, 1052–1062 (2022). https://doi.org/10.1007/s00259-021-05539-1
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DOI: https://doi.org/10.1007/s00259-021-05539-1