Actively Recruiting
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET
Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-06-04
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent called 99mTc-QULIC-5-P1, a radiotracer that targets PSMA, which may help detect lesions in patients with PSMA positive prostate cancer. This early phase 1 study aims to investigate the safety, how the agent spreads in the body, and its usefulness in imaging prostate cancer compared with a standard PET scan agent called 68Ga-PSMA-11. Participants will receive a single intravenous injection of 99mTc-QULIC-5-P1. The study involves one study group where this radiotracer is administered once, followed by imaging procedures to assess its diagnostic capabilities. The comparison with 68Ga-PSMA-11 PET imaging will help understand the performance of the new tracer. During the study, participants will undergo diagnostic imaging to evaluate the presence and location of prostate cancer lesions. Researchers will monitor safety and efficacy outcomes over 15 days, focusing on diagnostic effectiveness. The study includes consent procedures and excludes those with certain medical conditions or lack of PSMA expression. Total participation duration varies but includes initial administration and follow-up for outcome assessment.
CONDITIONS
Brief Title
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Signed informed consent
- Patients with suspected, newly diagnosed, or previously diagnosed prostate cancer with PSMA positive expression confirmed by MRI, CT, pathology, or similar evidence
You will not qualify if you...
- Patients with PSMA negative expression
- Patients who are pregnant
- Inability or unwillingness to provide written informed consent
- Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components
- Any serious medical condition that may interfere with study procedures or evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous injection of 99mTc-QULIC-5-P1 to assess prostate cancer through SPECT imaging.
1 visit (in-person)
Duration - 15 days
Participants are monitored for diagnostic efficacy and safety over the following 15 days.
Follow-up assessments during this period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
X
Xiaoyang Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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