Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Standardized uptake value (SUV)
研究概览
简要总结
To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.
详细描述
Subjects with liver fibrosis underwent 68Ga-FAPI-04 PET/CT scanning. Liver fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (TE) and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, TE and BBI were calculated and compared to evaluate the diagnostic efficacy.
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
- 否
入选标准
- •adult patients (aged 18 years or order)
- •patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include TE, BBI, MRI, CT and pathology report)
- •patients who had scheduled 68Ga-FAPI-04 PET/CT scan
- •patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee
排除标准
- •patients without liver fibrosis lesions
- •patients with pregnancy
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
研究组 & 干预措施
68Ga-FAPI-04 PET/CT scanning
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
干预措施: 68Ga-FAPI-04 (Drug)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: 30 days
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.
次要结局
- Blood biochemical indexes (BBI) testing(30 days)
- Liver stiffness measurement (LSM)(30 days)
研究者
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University