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

Primary Purpose

Liver Cirrhosis, Liver Steatosis, Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

7T Magnetic Resonance Imaging

About this trial

This is an interventional basic science trial for Liver Cirrhosis focused on measuring liver, cirrhosis, steatosis, hepatocellular carcinoma, pancreatic cancer, 7 tesla, magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Azienda Ospedaliero Universitaria PisanaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EX-VIVO SPECIMENS

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04012021

First Posted

July 4, 2019

Last Updated

July 4, 2019

Sponsor

University of Pisa

Collaborators

Azienda Ospedaliero, Universitaria Pisana, Imago 7

1. Study Identification

Unique Protocol Identification Number

NCT04012021

Brief Title

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

Acronym

EXLIPSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 24, 2019 (Actual)

Primary Completion Date

January 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pisa

Collaborators

Azienda Ospedaliero, Universitaria Pisana, Imago 7

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

liver, cirrhosis, steatosis, hepatocellular carcinoma, pancreatic cancer, 7 tesla, magnetic resonance imaging

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Three single groups to be included

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EX-VIVO SPECIMENS

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

7T Magnetic Resonance Imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Crocetti, MD,PhD

Phone

+39 050 99

Ext

5551

laura.crocetti@med.unipi.it

First Name & Middle Initial & Last Name or Official Title & Degree

Rosa Cervelli, MD

Phone

+39 050 99

Ext

5551

rosa.cervelli@virgilio.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Crocetti, MD,PhD

Organizational Affiliation

University of Pisa

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Ospedaliero Universitaria Pisana

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Crocetti, MD, PhD

Phone

+39 050 99

Ext

5551

laura.crocetti@med.unipi.it

First Name & Middle Initial & Last Name & Degree

Rosa Cervelli, MD

Phone

+ 39 050 99

Ext

5551

rosa.cervelli@virgilio.it

First Name & Middle Initial & Last Name & Degree

Davide Caramella, MD

First Name & Middle Initial & Last Name & Degree

Francesco Balducci, MD

First Name & Middle Initial & Last Name & Degree

Daniela Campani, MD

First Name & Middle Initial & Last Name & Degree

Andrea Cacciato Insilla, MD

First Name & Middle Initial & Last Name & Degree

Paolo De Simone, MD

First Name & Middle Initial & Last Name & Degree

Ugo Boggi, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24478137

Citation

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Results Reference

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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

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