68Ga-FAPI PET Imaging in Malignancy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of 68Ga-FAPI PET
研究概览
简要总结
This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.
详细描述
PRIMARY OBJECTIVE:
To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.
OUTLINE:
Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.
After completion of study, patients are followed up at 24-72 hours.
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
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with current malignancy confirmed via pathology or imaging
- •Patient must be > 18 years old
- •Patient must be willing and able to provide written informed consent for the trial
- •Patient of reproductive potential will have a pregnancy test
排除标准
- •Pregnant or breastfeeding
研究组 & 干预措施
68Ga-FAPI PET/CT
Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
干预措施: 68Ga-FAPI (Drug)
68Ga-FAPI PET/CT
Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
干预措施: Computed Tomography (CT) scan (Procedure)
68Ga-FAPI PET/CT
Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
干预措施: Positron Emission Tomography (PET) scan (Procedure)
结局指标
主要结局
Feasibility of 68Ga-FAPI PET
时间窗: 24 months
Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if \> 50% of scans will have a score of 3 or more
次要结局
未报告次要终点