PET Imaging With [68Ga]Ga-ELI421 Injection in People With Prostate Cancer
Tests [68Ga]Ga-ELI421 PET scans for safety and imaging in prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07689656, who can take part
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT07689656
- Record updated
- 8 July 2026
- Original description
Primary Objective:Read full original descriptionShow less
A Clinical Study on the Safety and Tolerability, Biodistribution, Radiation Dosimetry, and Diagnostic Efficacy of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
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.
Inclusion: Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures; Aged ≥ 18 years; In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; Patients with histopathologically and/or cytologically confirmed prostate cancer; Has an indication for PSMA PET imaging; No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results; Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.
Exclusion: Concomitant medications that may compromise subject safety or interfere with imaging results; Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results; Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to [⁶⁸Ga]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions; Any other conditions deemed inappropriate by the investigator for participation in this study; Presence of comorbidities that may compromise subject safety or interfere with imaging results; Inability to complete PET imaging as required.