First use of a new imaging agent for prostate cancer
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
This study is testing a new imaging agent to see if it can help doctors better identify and monitor prostate cancer in patients.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06612580 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a novel radiotracer, 68Ga-AAZTA-NI-093, which targets prostate-specific membrane antigen (PSMA) in patients with prostate cancer. The research focuses on assessing the biodistribution, radiation dosimetry, and diagnostic value of this agent using PET/CT imaging. It aims to provide insights into how well this new imaging technique can identify and monitor prostate cancer. The study is designed as an early-phase trial to gather initial data on the agent's performance in humans.
Who should consider this trial
Good fit: Ideal candidates for this study are men with confirmed treated or untreated prostate cancer.
Not a fit: Patients with known allergies to PSMA or those with medical conditions that may interfere with study compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy and monitoring of prostate cancer, leading to better patient management.
How similar studies have performed: Other studies have shown promise with similar PSMA-targeting approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Weibing Miao, MD — First Affiliated Hospital of Fujian Medical University
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: 86-0591-87981618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.