Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- The primary endpoint of the study for each patient is acquisition of PET/CT image.
研究概览
简要总结
The purpose of this study is to determine whether [18F]FHBG is suitable for use as an imaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients.
详细描述
The success of cell and gene therapy depends on specific targeting of the therapeutic gene or cell that is administered to the patient. Our goal is to develop an imaging method to non-invasively monitor the location of the therapeutic gene or cell. Imaging should help in the design of better protocols and potentially reduce side-effects of cell and gene therapy.
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
- •Clinical diagnosis of brain tumor or rheumatoid arthritis
排除标准
- •Below 18 years of age
结局指标
主要结局
The primary endpoint of the study for each patient is acquisition of PET/CT image.
时间窗: Time of scan
次要结局
- Collection of vital signs, EKG, blood chemistry and CBC data(day 1, 2 and 8.)
研究者
Sanjiv Sam Gambhir
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research
Stanford University