Diagnostic and Prognostic Role of 11C-Choline PET/CT and DWI MRI for Response Assessment in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to TARE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC
研究概览
简要总结
Prospective exploratory study specifically investigating the diagnostic and predictive role of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and candidate to TARE. A minimum number of 20 patients will be considered for the analysis.
详细描述
For the study, all patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included. In all cases, patients will undergo 11C-Choline PET/CT and DWI MRI before starting radioembolization and will be subsequently restaged 3 months after treatment completion. A minimum number of 20 patients will be considered for the analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included;
- •obtained informed consent
排除标准
- •patients age <18 years
- •pregnancy or breast-feeding;
- •patients affected by other malignancies within the last 3 years;
- •disseminated extrahepatic disease;
- •severely abnormal excretory liver function tests or ascites suggestive of liver failure;
- •hepatopulmonary shunt >20%;
- •vascular variants and abnormalities as demonstrated on pre-treatment angiography, which cannot be corrected by embolisation and which lead to reflux of hepatic arterial blood to the stomach, pancreas or bowel.
结局指标
主要结局
Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC
时间窗: Change from Baseline in SUVmax up to 3 months after TARE
次要结局
未报告次要终点