NCT06389682已完成1 期
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM005 Injection Prepared by Kit for the Preparation of the 68Ga-NYM005 Injection in Patients With Metastatic Clear Cell Renal Carcinoma.
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
- 19
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed metastatic renal clear cell carcinoma;
- •Age range from 18 to 75 years old (including 18 and 75 years old);
- •ECOG score of 0 or 1;
- •Expected life > 6 months;
- •GFR> 60 ml/min;
- •Women of childbearing age need to have a negative pregnancy test, and the subjects(including male subjects)agree to take effective contraceptive measures during the study period and for at least three months after the drug 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
- •Pregnant or lactating women, or women who plan to conceive during the study period or within three months after drug administration;
- •Known or suspected to be allergic to the investigational drug or any of its components,acetazolamide or other sulfonamides:
- •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;
- •On VEGF TKI treatment less than 7 days before 68Ga-NYM005 PET/CT, such as sunitinib,sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM005 PET/CT is required;
- •Planned (for the period between injection of 68Ga-NYM005 and imaging) antineoplastic therapies;
- •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-NYM005 injection
Experimental
干预措施: 68Ga-NYM005 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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