EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI

Study Overview
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Brief Summary
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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).

Official Title
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EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study

Conditions
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Magnetic Resonance Imaging, Liver Cirrhosis, Liver Steatosis, Hepatocellular Carcinoma, Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: 7T Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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GROUP A of Native Liver Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Three single groups to be included
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EX-VIVO SPECIMENS<br>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 | Diagnostic Test: 7T Magnetic Resonance Imaging<br>* T1-weighted and T2-weighted sequences quantitative magnetic resonance imaging approach proton spectrum analyses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver, cirrhosis, steatosis, hepatocellular carcinoma, pancreatic cancer, 7 tesla, magnetic resonance imaging