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.
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;
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;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Eli Radiopharma
Collaborator