EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluate the correlation between the characteristics detected by the MRI equipment and the histological composition of ex-vivo specimens from hepatic and pancreatic tissues and lesions
研究概览
简要总结
Aim of this study is to evaluate the correlation between the characteristics detected by the 7T MRI equipment and the histological composition of native explanted livers (group A), liver graft excluded for donation (group B) and surgical specimens of primary pancreatic tumour, which underwent pancreaticoduodenectomy (group C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •informed consent
- •full possession of one's faculties
- •patients who are going to undergo liver transplantation, independently from previous therapy or from the primary disease they are affected by.
排除标准
- •patients affected by polycystic liver disease
- •excluded from liver transplantation.
- •GROUP B of Excluded Grafts
- •Inclusion Criteria:
- •liver grafts with histologically proven macrovescic steatosis, not fit for transplantation
- •Exclusion Criteria:
- •liver grafts histologically proven macrovescic steatosis fit for transplantation
- •liver grafts not fit for transplantation due to causes other than steatosis
- •GROUP C of Focal Pancreatic Lesion
- •Inclusion Criteria:
- •informed consent
- •full possession of one's faculties
- •pancreatic lesion assessed by CT examination and histologically proved, which are candidates for pancreaticoduodenectomy or total pancreatectomy
- •Exclusion Criteria:
- •excluded from surgery due to the severity of their condition.
研究组 & 干预措施
EX-VIVO SPECIMENS
Three groups of ex-vivo surgical specimen:
Group A: native livers in transplant recipients Group B: liver grafts excluded for donation Group C: primary pancreatic cancer
干预措施: 7T Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Evaluate the correlation between the characteristics detected by the MRI equipment and the histological composition of ex-vivo specimens from hepatic and pancreatic tissues and lesions
时间窗: 3 years
The creation of a data-bank will increase the knowledge about imaging features able to characterize many diseases affecting the liver, and to evaluate cell changes that occur in pancreatic cancer and the tumour pathways of spreading; moreover it will provide a reference framework to define proper acquisition protocols for future clinical applications. Such data will also provide imaging biomarkers of malignant cells, and show the morphological changes that occur in neoplastic lesions after systemic or loco-regional therapies.
次要结局
未报告次要终点
研究者
Laura Crocetti
Associate Professor
University of Pisa