Imaging prostate cancer with a new radiotracer
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET
This study is testing a new imaging agent to see if it can help identify prostate cancer in patients whose tumors have a specific marker called PSMA.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06419348 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a new radiotracer, 99mTc-QULIC-5-P1, for SPECT imaging in patients with prostate cancer that expresses PSMA. The study aims to determine how well this imaging agent can identify lesions associated with PSMA positive prostate cancer. Participants will undergo imaging procedures to assess the biodistribution of the radiotracer and its potential usefulness in diagnosing prostate cancer. The trial is designed for early-phase evaluation, focusing on the initial safety and imaging capabilities of the agent.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or diagnosed prostate cancer that shows PSMA positive expression.
Not a fit: Patients with PSMA negative expression or serious medical conditions that may interfere with the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis and improve patient management.
How similar studies have performed: While this specific approach is novel, similar imaging techniques targeting PSMA have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc). Exclusion Criteria: 1. Patients with PSMA negative expression. 2. Patients with pregnancy. 3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Where this trial is running
Chongqing, Chongqing Municipality
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyang Zhang, PhD
- Email: zhangxy@mail.bnu.edu.cn
- Phone: 023-89011755
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.