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68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
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.
Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients.
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Start Date
September 1, 2024
Primary Completion Date
August 31, 2025
Completion Date
December 31, 2025
Last Updated
September 25, 2024
10
ESTIMATED participants
68Ga-AAZTA-NI-093
DRUG
Lead Sponsor
First Affiliated Hospital of Fujian Medical University
NCT06616597
NCT07115914
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