EXLIPSEEXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study
7T Magnetic Resonance Imaging
Adenocarcinoma+17
+ Carcinoma
+ Digestive System Diseases
Basic Science Study
Summary
Study start date: May 24, 2019
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Azienda Ospedaliero Universitaria Pisana
Pisa, ItalyOpen Azienda Ospedaliero Universitaria Pisana in Google Maps