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

Not Applicable

• Conditions: Pancreatic Cancer; Liver Cirrhosis; Hepatocellular Carcinoma; Magnetic Resonance Imaging; Liver Steatosis
• Interventions: Diagnostic Test: 7T Magnetic Resonance Imaging

• Registration Number: NCT04012021
• Lead Sponsor: University of Pisa

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-24
• Status Verified: 2019-07
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Last Update Submitted: 2019-07-04
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09
• Primary Completion: 2020-01-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EX-VIVO SPECIMENS	7T Magnetic Resonance Imaging	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

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, PI, Italy