A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-ELI421 injection.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug [68Ga]Ga-ELI421 injection
Administration Protocol: A single rapid intravenous bolus injection of \[68Ga\]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.
Primary outcome measures
- Adverse Event (AE) [Time frame: Day1, Day2-3]
Secondary outcome measures (3)
- Lesion uptake value [Time frame: Day1]
- Absorbed dose [Time frame: Day1]
- Diagnostic performance [Time frame: Day1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07689656 · Xlan-20260318