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

July 4, 2019 updated by: Laura Crocetti, University of Pisa

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Davide Caramella, MD
        • Sub-Investigator:
          • Francesco Balducci, MD
        • Sub-Investigator:
          • Daniela Campani, MD
        • Sub-Investigator:
          • Andrea Cacciato Insilla, MD
        • Sub-Investigator:
          • Paolo De Simone, MD
        • Sub-Investigator:
          • Ugo Boggi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EX-VIVO SPECIMENS

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

What is the study measuring?

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
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Collaborators

Azienda Ospedaliero, Universitaria Pisana
Imago 7

Investigators

  • Principal Investigator: Laura Crocetti, MD,PhD, University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 24, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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