68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic performance2
研究概览
简要总结
FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
详细描述
Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in suspicion of oral carcinoma,
- •68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
- •being able to provide basic information and sign the written informed consent form.
排除标准
- •claustrophobia,
- •pregnancy,
- •breastfeeding,
- •kidney or liver failure,
- •inability to fulfill the study.
研究组 & 干预措施
68Ga-FAPI-04 PET/CT
The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.
干预措施: 68Ga-FAPI-04 (Drug)
结局指标
主要结局
Diagnostic performance2
时间窗: 1 year
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Diagnostic performance1
时间窗: 1 year
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
次要结局
未报告次要终点