PSMA Clinical Trial
Official title:
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET
99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | June 30, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital of Chongqing Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic efficacy | The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT | 15 days |