NCT07689656RecruitingPhase 1/2
A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 8 Jun 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Prostate cancer
- NCT number
- NCT07689656
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 8 Jun 2026 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Other
- Presence of comorbidities that may compromise subject safety or interfere with imaging results;
- Inability to complete PET imaging as required;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.