NCT07464132招募中1 期
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04
研究概览
简要总结
The purpose of this study is to conduct clinical research on [68Ga] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1: 18-85 years old
- •2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis
- •3: Ability to understand and sign informed consent forms
- •4: Expected survival period exceeding 6 months and able to receive follow-up
- •5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc
排除标准
- •1: Pregnant or lactating women
- •2: Patients allergic to research drug ingredients
- •3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)
- •4: Patients who participate in other clinical trials and interfere with the results of this study
- •5: Patients with severe illness who cannot cooperate with the examination
研究组 & 干预措施
NI-FAPI group
Experimental
Injection of [68Ga]Ga-NI-FAPI
干预措施: Injection of 68Ga-NI-FAPI (Drug)
结局指标
主要结局
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04
时间窗: Within 30-120 minutes after intravenous injection of imaging agent
Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)
次要结局
未报告次要终点
研究者
Zhaohui Zhu
Chief physician
Peking Union Medical College Hospital
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Role of [68Ga]Ga-FAPI PET/CT in oncological patients with doubtful or inconclusive findings at [18F]F-FDG PET/CT2024-518765-96-00Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico200
招募中
2 期
[68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer2023-503632-41-01Rigshospitalet
撤回
2 期
[68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer2023-503632-41-00Rigshospitalet60
招募中
2 期
The use of [68Ga]Ga-FAPI PET/MRI in assessing disease activity in patients with Graves’ orbitopathy2025-521163-12-01Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)10
招募中
1 期
Performance and prognostic value of 68Ga-FAPI PET/CT in non-small cell lung cancer (NSCLC)2023-503985-21-00Meander Medical Center20