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

NCT04012021 | Unknown

• 1 other identifier: 13646
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (1)

EX-VIVO SPECIMENS

EXPERIMENTAL

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

Interventions

7T Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

EX-VIVO SPECIMENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients affected by polycystic liver disease
• excluded from liver transplantation.
• GROUP B of Excluded Grafts
• \- liver grafts with histologically proven macrovescic steatosis, not fit for transplantation
• 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
• 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
• \- excluded from surgery due to the severity of their condition.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: collaborator
• University of Pisa: lead
• Imago 7: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, 56124, Italy

RECRUITING

Related Publications (17)

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  PMID: 26502373 BACKGROUND

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  PMID: 23855291 BACKGROUND

• Meyers RL, Tiao GM, Dunn SP, McGahren ED 3rd, Langham MR Jr; Central Surgical Review Committee, Children's Oncology Group AHEP-0731, Treatment of Children with All Stages Hepatoblastoma. Surgical management of children with locally advanced hepatoblastoma. Cancer. 2012 Aug 15;118(16):4090-1; author reply 4094-5. doi: 10.1002/cncr.26715. Epub 2012 Jul 3. No abstract available.

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  PMID: 12360427 BACKGROUND

• Sposito C, Droz Dit Busset M, Citterio D, Bongini M, Mazzaferro V. The place of liver transplantation in the treatment of hepatic metastases from neuroendocrine tumors: Pros and cons. Rev Endocr Metab Disord. 2017 Dec;18(4):473-483. doi: 10.1007/s11154-017-9439-7.

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• Nakao A, Harada A, Nonami T, Kaneko T, Takagi H. Clinical significance of carcinoma invasion of the extrapancreatic nerve plexus in pancreatic cancer. Pancreas. 1996 May;12(4):357-61. doi: 10.1097/00006676-199605000-00006.

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MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Carcinoma, Hepatocellular; Pancreatic Neoplasms; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Laura Crocetti, MD,PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three single groups to be included

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: May 24, 2019
• Primary Completion: January 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)