Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with contrast-enhanced MRI.
详细描述
This study is designed to investigate GPC3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma. In this research, eligible patients will undergo contemporaneous GPC3-targeted PET/CT and contrast-enhanced liver MRI plus conventional extrahepatic imaging either for initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake will be quantified by the maximum standardized uptake value (SUVmax). Positive lesions detected by contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..
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 90 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 older);
- •Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);
- •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.
- •Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
排除标准
- •Lack of contrast-enhanced liver MRI or an interval of more than 14 days between GPC3-targeted PET/CT and contrast-enhanced liver MRI.
- •Receipt of antitumor treatment between imaging examinations.
- •The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- •Inability to complete PET/CT imaging.
研究组 & 干预措施
GPC3-targeted PET/CT
Each subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time.
干预措施: GPC3-targeted PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic efficacy
时间窗: 1 year
The sensitivity, specificity, and accuracy of 18F-FDG PET/CT and GPC3-targeted PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Diagnostic accuracy
时间窗: 1 year
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
次要结局
- Gastric SUVmax Stratified by Gastric Filling Status(1 day)
- Agreement of BCLC classification with the reference classification(1 year)
- Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT(Within 14 days)