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Recruiting EARLY_Phase 1 NCT06612580
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
Trial Parameters
Condition Prostate Cancer (Adenocarcinoma)
Sponsor First Affiliated Hospital of Fujian Medical University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 10
Sex MALE
Min Age 18 Years
Max Age 80 Years
Start Date 2024-09-01
Completion 2025-08-31
Interventions
68Ga-AAZTA-NI-093
Brief Summary
68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in patients with prostate cancer.
Eligibility Criteria
Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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