Actively Recruiting
Early Phase 1 Study of 68Ga-AAZTA-NI-093 PETCT Imaging in Men With Prostate Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-09-25
10
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Prostate cancer is a common cancer in men, and this research focuses on a novel imaging agent called 68Ga-AAZTA-NI-093. This agent combines a hypoxia-sensitive nitroimidazole component with a prostate-specific membrane antigen PSMA targeting molecule. The study aims to evaluate the safety, how the agent spreads in the body, radiation dose levels, and its value in diagnosing prostate cancer using PETCT scans. Participants will receive a single intravenous injection of 68Ga-AAZTA-NI-093 at a dose of 111-148 MBq 3-4 mCi. The radiotracer is designed to highlight prostate cancer lesions during PETCT imaging. This is a first-in-human, early phase 1 study to observe these effects and collect imaging data. During the study, patients will be monitored for any adverse events within 7 days after the PETCT scan. Radiation dosimetry data will be collected throughout the study lasting about 3 months. The researchers will assess safety, biodistribution, and diagnostic accuracy, involving imaging and follow-up evaluations to understand the tracers performance and patient tolerance.
CONDITIONS
Brief Title
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
Research Team
W
Weibing Miao, MD
G
Guochang Wang, MD
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