NCT07689656 A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
| NCT ID | NCT07689656 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-06-08 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures; 2. Aged ≥ 18 years; 3. In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 4. Patients with histopathologically and/or cytologically confirmed prostate cancer; 5. Has an indication for PSMA PET imaging; 6. 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. 7. 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 Criteria: 1. Presence of comorbidities that may compromise subject safety or interfere with imaging results; 2. Concomitant medications that may compromise subject safety or interfere with imaging results; 3. Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results; 4. Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions; 5. Inability to complete PET imaging as required; 6. Any other conditions deemed inappropriate by the investigator for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07689656 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07689656 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07689656 currently recruiting?
Yes, NCT07689656 is actively recruiting participants. Contact the research team at hzslxl@163.com for enrollment information.
Where is the NCT07689656 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07689656 clinical trial?
NCT07689656 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 50 participants.
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