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Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
Sponsor: HTA Co., Ltd.
Summary
In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging. This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).
Official title: A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
287
Start Date
2023-10-20
Completion Date
2026-04-16
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
[18F]Florastamin Injection
The subjects who participate in phase 3 study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, China