NCT06612580 68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
| NCT ID | NCT06612580 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-09-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Weibing Miao, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT06612580 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06612580 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06612580 currently recruiting?
Yes, NCT06612580 is actively recruiting participants. Contact the research team at miaoweibing@126.com for enrollment information.
Where is the NCT06612580 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06612580 clinical trial?
NCT06612580 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Weibing Miao, MD at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 10 participants.
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