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

N/AUnknownNCT04012021

University of Pisa30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis Liver Steatosis Hepatocellular Carcinoma Pancreatic Cancer Magnetic Resonance Imaging

Interventions

7T Magnetic Resonance ImagingDIAGNOSTIC_TEST

* T1-weighted and T2-weighted sequences * quantitative magnetic resonance imaging approach * proton spectrum analyses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Central Contacts

Laura Crocetti, MD,PhD

CONTACT

+39 050 99 laura.crocetti@med.unipi.it

Rosa Cervelli, MD

CONTACT

+39 050 99 rosa.cervelli@virgilio.it

Data from ClinicalTrials.gov

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