NCT03094897Unknown早期 1 期
Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
Wuxi No. 4 People's Hospital0 个研究点目标入组 30 人开始时间: 2017年4月20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
- 发起方
- 入组人数
- 30
- 主要终点
- Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
研究概览
简要总结
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（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-MATBBN PET/CT
Experimental
Imaging with 18F-Al-NOTA-MATBBN PET/CT
干预措施: 18F-Al-NOTA-MATBBN PET/CT (Drug)
18F-Al-NOTA-MATBBN PET/CT
Experimental
Imaging with 18F-Al-NOTA-MATBBN PET/CT
干预措施: PET/CT (Device)
结局指标
主要结局
Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
时间窗: 1 day
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions will be measured.
次要结局
- Adverse events collection(1 week)
研究者
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