1. A microdose clinical trial to evaluate [18F]Florastamin as a positron emission tomography imaging agent in patients with prostate cancer.
- Author
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Lee, Inki, Lim, Ilhan, Byun, Byung Hyun, Kim, Byung Il, Choi, Chang Woon, Woo, Sang-Keun, Lee, Kyo Chul, Kang, Joo Hyun, Kil, Hee Seup, Park, Chansoo, Chi, Dae Yoon, Park, Jongwook, Song, Kanghyon, and Lim, Sang Moo
- Subjects
PROSTATE cancer patients ,POSITRON emission tomography ,EXOCRINE glands ,RADIATION dosimetry ,LYMPHATIC metastasis ,CLINICAL trials ,ABSORBED dose ,SALIVARY glands - Abstract
Purpose: To evaluate the biodistribution of [
18 F]Florastamin, a novel18 F-labelled positron emission tomography (PET) tracer for prostate-specific membrane antigen (PSMA) for the diagnosis of prostate cancer. Methods: PET was performed for five healthy controls and 10 patients with prostate cancer at 0, 10, 30, 70, and 120 mins after injecting 370 MBq of [18 F]Florastamin. The maximum standardised uptake value (SUVmax ) was evaluated in the primary tumour. The mean SUVmax (SUVmean ) was evaluated in normal organs. Furthermore, the residence time was evaluated by assessing radioactivity in each organ. The internal radiation dosimetry was calculated using the OLINDA/EXM software. Results: The SUVmax in primary tumours increased with time. A favourable tumour to background ratio was also observed over time. Multiple lymph nodes and bone metastases were also evaluated and showed a similar pattern to SUVmax in the primary tumour. In one patient, a tiny lymph node metastasis was identified using [18 F]Florastamin PET, which was not observed using other modalities, and was histologically confirmed. The highest absorbed dose was observed in the kidney (0.062 ± 0.015 mGy/MBq), followed by the bladder (0.032 ± 0.013 mGy/MBq), liver (0.022 ± 0.006 mGy/MBq), and salivary gland (0.018 ± 0.006 mGy/MBq). The effective dose with a 370 MBq injection of [18 F]Florastamin was 1.81 mSv. No adverse events related to [18 F]Florastamin were reported. Conclusion: We identified a novel PSMA-targeted PET ligand, [18 F]Florastamin, for imaging prostate cancer. [18 F]Florastamin showed a high SUVmax and relatively high tumour to background ratio in both primary tumour and metastatic lesions, which suggests its high sensitivity to detect tumours without any adverse events. Trial registration: KCT0003924 registered at https://cris.nih.go.kr/. [ABSTRACT FROM AUTHOR]- Published
- 2021
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