Safety Study of 89Zr-NY001 PET Imaging in Patients With Fibronectin ED-B Positive Solid Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.
详细描述
After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.
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
- •Patients voluntarily signed informed consent;
- •Aged >18, male or female;
- •Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
- •At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- •Patients with biopsy-proven fibronectin ED-B positive;
- •ECOG score ≤ 0~3; Life expectancy of at least 3 months;
- •Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
- •ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
- •Other routine examinations are within the normal range or considered acceptable by the researchers.
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 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.
结局指标
主要结局
Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.
时间窗: 1 year
Degree and localization of focal lesion compared with that of 18F-FDG PET scans and according to the expression of fibronectin ED-B domain will be reported.
次要结局
未报告次要终点