NCT05623878招募中早期 1 期
68Ga-labeled NY108 PET Imaging in Patients
Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.
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 voluntarily signed informed consent;
- •Age 18-75, male;
- •Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
- •At least one measurable solid lesion has been examined according RECIST1.1 standard;
- •Patients with biopsy-proven PSMA positive;
- •ECOG score 0~3; Life expectancy of at least 3 months;
排除标准
- •Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- •Patients with systemic or locally severe infections, or other serious coexisting diseases;
- •Patients with allergies or allergies to any component of the imaging agent or antibody;
- •Patients who cannot perform PET/CT imaging scan;
- •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;
- •Syphilis, HBV, HCV, or HIV positive subjects;
- •Male subjects of reproductive age cannot take effective contraceptive measures;
- •Patients with a history of mental illness or related conditions;
- •Other subjects considered unsuitable by researchers.
研究组 & 干预措施
68Ga-Anti-PSMA mAbs
Experimental
干预措施: 68Ga-labeled NY108 (Drug)
结局指标
主要结局
Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
时间窗: 1 year
Biodistribution of 68Ga-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
次要结局
- Incidence of Treatment-Emergent Adverse Events(1 year)
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University
研究点 (1)
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