NCT06287411招募中不适用
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Xiao Chen1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Diagnostic performance
研究概览
简要总结
This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.
详细描述
- Clinical and biological data, including the course of disease, underlying liver disease (hepatitis or cirrhosis), serum alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient.
- PET image analysis: Each patient underwent both FAPI and fluorodeoxyglucose (FDG) PET/MR, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), apparent diffusion coefficient (ADC) and gadoxetate disodium-enhanced MRI. Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the target-to-background ratio (TBR) which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue.
- Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 (GLUT-1) and fibroblast activation protein (FAP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient ≥ 18 years of age at the time of consent;
- •Patients with suspected, newly diagnosed, or previously treated liver cancer;
- •Estimated creatinine clearance > 30ml/min;
- •Provided written informed consent authorisation before participating in the study.
排除标准
- •Allergic to the gadoxetate disodium；
- •MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
- •Weight > 90Kg;
- •Pregnancy or lactation;
- •Active inflammation may affect FAPI imaging.
结局指标
主要结局
Diagnostic performance
时间窗: through study completion, an average of 2 years
sensitivity, specificity, accuracy, positive and negative predictive values
次要结局
- Quantitative parameters of PET/MR(completed within one week after the PET examination)
研究者
Xiao Chen
Director of Nuclear Medicine Department
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (1)
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