The Role of Novel PET Molecular Imaging Targeting Fibroblast Activation Protein in the Diagnosis of Hepatobiliary Malignancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- diagnose accordance rate
研究概览
简要总结
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies
详细描述
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign a written informed consent;
- •18-80 years old (inclusive) male or female;
- •Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
- •Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
- •Have willingness and ability to participate in all research procedures.
排除标准
- •Women who are pregnant or breastfeeding;
- •Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
- •Those who have a history of other malignant tumors in the past;
- •Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
- •Patients with claustrophobia;
- •Those who cannot tolerate lying down for 15-30 minutes;
- •The researchers believe that it is not suitable to participate in this clinical trial;
- •Those who have participated in clinical trials or are participating in other clinical trials within the past month
结局指标
主要结局
diagnose accordance rate
时间窗: 2022.1.20-2022.7.30
Proportion of PET/CT diagnostic reports consistent with pathological results
次要结局
- Tumor Background Ratio(2022.1.20-2022.7.30)
- Standardized Uptake Mean (SUVmean)(2022.1.20-2022.7.30)
- Standardized Uptake Maximum (SUVmax)(2022.1.20-2022.7.30)
- Tumor Metabolic Volume (MTV)(2022.1.20-2022.7.30)
- Total Glycolysis (TLG)(2022.1.20-2022.7.30)
研究者
Yufeng Yuan
professor
Zhongnan Hospital