First Affiliated Hospital of Chongqing Medical University
Phase
Phase EARLY_PHASE1
Started
2024-05-20
Last updated
2025-06-04
Condition(s) studied
Prostate Cancer StagePSMASPECT
Investigational drug(s) / intervention(s)
99mTc-QULIC-5-P1
99mTc-QULIC-5-P1: Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Diagnostic efficacy — 15 days The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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