A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Recruiting · NCT07689656 · Interventional (participants receive a specific treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the official record on ClinicalTrials.gov →Interventions studied
[68Ga]Ga-ELI421 injection
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Presence of comorbidities that may compromise subject safety or interfere with imaging results;
- 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;
- Inability to complete PET imaging as required;
- Any other conditions deemed inappropriate by the investigator for participation in this study.
Where it is running
1 location listed.
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China