NCT06612580

68Ga-AAZTA-NI-093 PET/CT: First-in-human Study

68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer (Adenocarcinoma)

Interventions

Type	Name	Description
DRUG	68Ga-AAZTA-NI-093	Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-NI-093. Tracer doses of 68Ga-AAZTA-NI-093 will be used to image lesions of prostate cancer by PET/CT.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2024-09-25
• Last updated: 2024-09-25

Locations

1 site across 1 country: China