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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adverse Event (AE)
时间窗: Day1, Day2-3
Any abnormality, medication, or treatment after dosing shall be documented as an adverse event and concomitant medication / non-pharmacological treatment. All adverse events shall be followed up until resolution, stabilization or remission of symptoms, or until abnormal laboratory values return to normal, baseline or a stable state, or until a reasonable explanation is obtained (e.g., loss to follow-up, death).
次要结局
- Lesion uptake value(Day1)
- Absorbed dose(Day1)
- Diagnostic performance(Day1)