Actively Recruiting
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients 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
On this page
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 PET/CT 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 PET/CT 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 PET/CT 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 tracer's performance and patient tolerance.
CONDITIONS
Brief Title
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed treated or untreated prostate cancer patients
- Signed written consent
You will not qualify if you...
- Known allergy against PSMA
- Any medical condition that may significantly interfere with study compliance according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of 68Ga-AAZTA-NI-093 and undergo PET/CT imaging to evaluate prostate cancer lesions.
1 visit (in-person)
Duration - Up to 3 months
Participants are monitored for adverse events and dosimetry data collection following the PET/CT imaging.
Follow-up visits as needed up to 7 days for adverse events; additional monitoring through study completion
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
G
Guochang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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