Prostate Cancer Stage, PSMA, SPECT
Conditions
Brief summary
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.
Interventions
DRUG99mTc-QULIC-5-P1
Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | 15 days | The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT |
Countries
China
Contacts
Primary ContactXiaoyang Zhang, PhD
Outcome results
None listed