NCT06389695已完成1 期
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed prostate cancer;
- •Age range from 18 to 75 years old (including 18 and 75 years old);
- •ECOG score of 0 or 1;
- •Expected life ≥ 6 months；
- •The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
- •The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.
排除标准
- •Known or suspected to be allergic to the investigational drug or any of its components;
- •Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
- •Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
- •Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
- •Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；
- •Ongoing toxicity >grade l from previous standard or investigational therapies；
- •Patients with active infections during screening;
- •Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
- •Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
研究组 & 干预措施
68Ga-NYM032 injection
Experimental
干预措施: 68Ga-NYM032 injection (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 5 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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