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Safety and Diagnostic Evaluation of 68GaGa-ELI421 PET Imaging in Men with Prostate Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-07-08
50
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of PET imaging using a single intravenous infusion of 68GaGa-ELI421 injection in men with prostate cancer. This study also aims to assess the distribution, radiation exposure, and diagnostic effectiveness of 68GaGa-ELI421 PET imaging. It is a Phase 1 and Phase 2 interventional trial conducted by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive a single rapid intravenous injection of approximately 185 MBq 5 mCi of 68GaGa-ELI421 followed by a saline flush. Whole-body static or dynamic PET scans will be performed using this agent. Additionally, PSMA PET imaging will be done according to routine clinical practice. This study involves only one treatment arm focusing on dual PET imaging with ELI421 and PSMA for prostate cancer. During the study, participants will be monitored for adverse events on the first three days after injection. Researchers will measure lesion uptake, absorbed radiation dose, and diagnostic performance on Day 1. Safety assessments include physical exams, vital signs, laboratory tests, and ECG. Participation may last up to the study completion date in December 2026, with all procedures aimed at evaluating the imaging agents safety and diagnostic value.
CONDITIONS
Brief Title
A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Research Team
X
Xiaoli Lan
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