Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Permeability Surface (PS) According to Degree of Lesions Differentiation
研究概览
简要总结
The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery.
排除标准
- •Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.
研究组 & 干预措施
CT perfusion
arm with CT perfusion
干预措施: Xenetix-CT perfusion imaging (Drug)
结局指标
主要结局
Permeability Surface (PS) According to Degree of Lesions Differentiation
时间窗: Within a week from CT perfusion to surgery
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Blood Flow (BF) According to Degree of Lesions Differentiation
时间窗: Within a week from CT perfusion to surgery
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Blood Volume (BV) According to Degree of Lesions Differentiation
时间窗: Within a week from CT perfusion to surgery
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
次要结局
- Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation(Within a week from CT perfusion to surgery)
- Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)(Within a week from CT perfusion to surgery)
- Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)(Within a week from CT perfusion to surgery)
- Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation(Within a week from CT perfusion to surgery)
- Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation(Within a week from CT perfusion to surgery)
- Blood Volume According to Immunohistochemistry Parameter (CD31)(Within a week from CT perfusion to surgery)
- Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation(Within a week from CT perfusion to surgery)
- Blood Flow According to Immunohistochemistry Parameter (CD31)(Within a week from CT perfusion to surgery)
- Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)(Within a week from CT perfusion to surgery)
- Permeability Surface According to Immunohistochemistry Parameter (CD31)(Within a week from CT perfusion to surgery)