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

NCT06612580 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase EARLY_PHASE1

Started

2024-09-01

Last updated

2024-09-25

Condition(s) studied

Prostate Cancer (Adenocarcinoma)

Investigational drug(s) / intervention(s)

68Ga-AAZTA-NI-093

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.

Study 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

Sex

MALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Adverse events — Within 7 days following PET/CT
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06612580 on ClinicalTrials.gov ↗ ← All trials in China