An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
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
- Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
研究概览
简要总结
This early phase I trial determines where and to what degree the tracer [68Ga] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research [68Ga] Ga-FAPI-04. Because some cancers take up [68Ga] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age ≥ 18 years old
- •Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
- •Previous low uptake of [68Ga] Ga-DOTATATE PET/CT scan OR
- •Krenning Score ≥ 3 OR
- •Ki67 index ≥ 20%
- •Able to lie flat for 60 minutes
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Pregnancy or lactation
- •Patient recently underwent surgery with wound healing
研究组 & 干预措施
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
干预措施: Computed Tomography (Procedure)
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
干预措施: Gallium Ga 68-DOTA-FAPI-04 (Drug)
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
时间窗: Day 1
Pharmacokinetics of [68Ga] Ga-FAPI-04
时间窗: Day 1
We will monitor/measure the amount of Ga-FAPI-04 seen within different tissue in patients that have neuroendocrine tumors. We will specifically measure the ratio of uptake in the tumors in comparison to reference tissues such as liver or muscle.
次要结局
- Clinical diagnostic performance of [68Ga] Ga-FAPI-04(Day 1)
- Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors(Day 1)
- Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors(Day 1)