First use of a new radiotracer for prostate cancer imaging
68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
This study is testing a new imaging tool for prostate cancer to see if it works better than existing options in helping doctors find the cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06437496 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a novel radiotracer, 68Ga-AAZTA-093, in detecting prostate cancer using PET/CT imaging. It involves comparing the biodistribution and diagnostic value of this new tracer against established tracers, 68Ga-PSMA-11 and 68Ga-PSMA-617, in patients with confirmed prostate cancer. The study aims to gather data on radiation dosimetry and the overall diagnostic performance of the new radiotracer. Participants will undergo imaging within one week of receiving the different tracers to assess their effectiveness.
Who should consider this trial
Good fit: Ideal candidates include men with confirmed treated or untreated prostate cancer who can provide informed consent.
Not a fit: Patients with known allergies to PSMA or those with medical conditions that may interfere with compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging techniques for better diagnosis and management of prostate cancer.
How similar studies have performed: Other studies have shown success with similar PSMA-targeting approaches, indicating a promising avenue for prostate cancer imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week; * 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
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- 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.