drugset / Trial / NCT07689656
A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Phase 1/2
Recruiting
50 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eli Radiopharma · collab
NaSingle-groupOpen-labelDiagnostic
Summary
Primary Objective: To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \[⁶⁸Ga\]Ga-ELI421 injection in patients with prostate cancer. Secondary Objectives: To evaluate the biodistribution characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \[⁶⁸Ga\]Ga-ELI421 injection.
Timeline
- Start
- 2026-06-08
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [68Ga]Ga-ELI421 | Diagnostic / imaging agent | 185 mbq | Intravenous |