First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Blood Clearance
研究概览
简要总结
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.
详细描述
Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
99mTc-RWY SPECT/CT
Volunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later.
干预措施: 99mTc-RWY (Drug)
结局指标
主要结局
Blood Clearance
时间窗: 1,3,5,10,15,30,60,120 minutes post-injection
The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.
Excretion
时间窗: 0-24 hours post-injection
The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.
Biodistribution
时间窗: 0.5,1,2,4,24 hours post-injection
Area under the activity-time curve from hour 0 to last measurable activity.
SPECT/CT imaging
时间窗: post-injection
Image brightness is observed。
Distributed in organs
时间窗: 0.5,1,2,4,24 hours post-injection
The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.
次要结局
- Incidence of adverse events(1 week post-injection)
研究者
Fan Wang
Professor
Beijing University Health Science Center