Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy
研究概览
简要总结
This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.
详细描述
This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography [18F]FAraG (VisAcT) in cancer patients selected for immunotherapy and/or radiation therapy. Each patient may have up to two [ 18F]FAraG PET imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging session, patients will receive a single injection of [18F]FAraG and undergo a whole-body PET scans an hour after injection of the tracer. Following each imaging session, the patient will be called within 72 hours to note any side effects.
Optional - Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of [18F]FAraG in addition an urine sample may be collected post scan.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients with identified tumor mass
- •Cancer patients expected to undergo immunotherapy and/or radiation therapy
排除标准
- •Under the age of 18
- •Pregnant women
- •Women who are breastfeeding
- •Individuals with known or suspected substance abuse
- •Individuals unable or unwilling to comply with the study procedures
结局指标
主要结局
Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy
时间窗: Up to 6 weeks before immunotherapy is administered
Whole-body \[18F\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.consecutive time points the day of the intravenous injection of the PET tracer.
Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy
时间窗: Up to 12 weeks after start of immunotherapy
Whole-body \[18F\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.
次要结局
未报告次要终点