NCT02441972Unknown1 期
Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Wuxi No. 4 People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
研究概览
简要总结
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
详细描述
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers or patients with age more than 18 yeas;
- •The patients have been diagnosed with cancer or suspected with cancer;
- •It must fulfill the ethical requirements and subjects have signed an informed consent.
排除标准
- •Pregnancy or nursing mothers;
- •Having drugs or alcohol dependence;
- •Hypersensitive to the active or inactive ingredients of the study drug;
- •Having attended other drug clinical trials within three months;
- •Cardiac functional insufficiency;
- •Hepatic and renal function insufficiency;
- •Hypertensive patients with serious complications;
- •Endangering the safety of life.
研究组 & 干预措施
18F-Al-NOTA-PRGD2 PET/CT
Experimental
Imaging with 18F-Al-NOTA-PRGD2 PET/CT.
干预措施: 18F-Al-NOTA-PRGD2 PET/CT (Drug)
结局指标
主要结局
Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
时间窗: 1 day
Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events.
次要结局
- radioactive distribution of normal organ, standard uptake value of tumor(60 minutes)
- Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"(1 day-1 year)
研究者
研究点 (1)
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