NCT05655676招募中早期 1 期
89Zr-labeled NY008 PET Imaging in Patients
Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of tissue distribution of 89Zr-NY008
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years old, male or female;
- •Patients diagnosed with relapsing or refractory multiple myeloma；
- •ECOG score 0~2；
排除标准
- •Life expectancy of less than 3 months;
- •Participated in other clinical research within 1 month;
- •Recovery from major trauma (including surgery) within 28 days prior to study treatment;
- •Patients with systemic or locally severe infections, or other serious coexisting diseases;
- •Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- •Patients with autoimmune diseases, including rheumatoid arthritis;
- •Inadequate control of arrhythmias, including atrial fibrillation;
- •Uncontrolled hypertension;
- •Patients with allergies or allergies to any component of the imaging agent or antibody;
- •Patients who cannot undergo PET/CT imaging scan;
- •Syphilis, HBV, HCV, or HIV positive subjects;
- •Male and female subjects of reproductive age cannot take effective contraceptive measures;
- •Pregnant or lactating women;
- •Patients with a history of mental illness or related conditions;
- •Other subjects considered unsuitable by researchers.
研究组 & 干预措施
89Zr-NY008
Experimental
干预措施: 89Zr-NY008 (Drug)
结局指标
主要结局
Evaluation of tissue distribution of 89Zr-NY008
时间窗: 7 days
Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.
次要结局
未报告次要终点
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University
研究点 (1)
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