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出境医 / 临床实验 / EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI (EXLIPSE)

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

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).

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Liver Steatosis Hepatocellular Carcinoma Pancreatic Cancer Magnetic Resonance Imaging Diagnostic Test: 7T Magnetic Resonance Imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Three single groups to be included
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 [ 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Contacts
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Contact: Laura Crocetti, MD,PhD +39 050 99 ext 5551 laura.crocetti@med.unipi.it
Contact: Rosa Cervelli, MD +39 050 99 ext 5551 rosa.cervelli@virgilio.it

Locations
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Italy
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, PI, Italy, 56124
Contact: Laura Crocetti, MD, PhD    +39 050 99 ext 5551    laura.crocetti@med.unipi.it   
Contact: Rosa Cervelli, MD    + 39 050 99 ext 5551    rosa.cervelli@virgilio.it   
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         
Sponsors and Collaborators
University of Pisa
Azienda Ospedaliero, Universitaria Pisana
Imago 7
Investigators
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Principal Investigator: Laura Crocetti, MD,PhD University of Pisa
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE May 24, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI
Official Title  ICMJE EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Three single groups to be included
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Liver Cirrhosis
  • Liver Steatosis
  • Hepatocellular Carcinoma
  • Pancreatic Cancer
  • Magnetic Resonance Imaging
Intervention  ICMJE Diagnostic Test: 7T Magnetic Resonance Imaging
  • T1-weighted and T2-weighted sequences
  • quantitative magnetic resonance imaging approach
  • proton spectrum analyses
Study Arms  ICMJE 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

Intervention: Diagnostic Test: 7T Magnetic Resonance Imaging
Publications *
  • Kraff O, Fischer A, Nagel AM, Mönninghoff C, Ladd ME. MRI at 7 Tesla and above: demonstrated and potential capabilities. J Magn Reson Imaging. 2015 Jan;41(1):13-33. doi: 10.1002/jmri.24573. Epub 2014 Jan 30. Review.
  • Pohmann R, Speck O, Scheffler K. Signal-to-noise ratio and MR tissue parameters in human brain imaging at 3, 7, and 9.4 tesla using current receive coil arrays. Magn Reson Med. 2016 Feb;75(2):801-9. doi: 10.1002/mrm.25677. Epub 2015 Mar 29.
  • Stephenson MC, Gunner F, Napolitano A, Greenhaff PL, Macdonald IA, Saeed N, Vennart W, Francis ST, Morris PG. Applications of multi-nuclear magnetic resonance spectroscopy at 7T. World J Radiol. 2011 Apr 28;3(4):105-13. doi: 10.4329/wjr.v3.i4.105.
  • Terpstra M, Cheong I, Lyu T, Deelchand DK, Emir UE, Bednařík P, Eberly LE, Öz G. Test-retest reproducibility of neurochemical profiles with short-echo, single-voxel MR spectroscopy at 3T and 7T. Magn Reson Med. 2016 Oct;76(4):1083-91. doi: 10.1002/mrm.26022. Epub 2015 Oct 26.
  • Zakhari S. Bermuda Triangle for the liver: alcohol, obesity, and viral hepatitis. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:18-25. doi: 10.1111/jgh.12207. Review.
  • 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.
  • Grossman EJ, Millis JM. Liver transplantation for non-hepatocellular carcinoma malignancy: Indications, limitations, and analysis of the current literature. Liver Transpl. 2010 Aug;16(8):930-42. doi: 10.1002/lt.22106. Review.
  • Dhir M, Lyden ER, Smith LM, Are C. Comparison of outcomes of transplantation and resection in patients with early hepatocellular carcinoma: a meta-analysis. HPB (Oxford). 2012 Sep;14(9):635-45. doi: 10.1111/j.1477-2574.2012.00500.x. Epub 2012 Jun 19. Review.
  • Lim KB, Schiano TD. Long-term outcome after liver transplantation. Mt Sinai J Med. 2012 Mar-Apr;79(2):169-89. doi: 10.1002/msj.21302. Review.
  • Yao FY. Liver transplantation for hepatocellular carcinoma: beyond the Milan criteria. Am J Transplant. 2008 Oct;8(10):1982-9. doi: 10.1111/j.1600-6143.2008.02351.x. Epub 2008 Aug 22. Review.
  • Yao FY, Bass NM, Nikolai B, Davern TJ, Kerlan R, Wu V, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: analysis of survival according to the intention-to-treat principle and dropout from the waiting list. Liver Transpl. 2002 Oct;8(10):873-83.
  • 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. Review.
  • 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.
  • Lehmann A, Denkert C, Budczies J, Buckendahl AC, Darb-Esfahani S, Noske A, Müller BM, Bahra M, Neuhaus P, Dietel M, Kristiansen G, Weichert W. High class I HDAC activity and expression are associated with RelA/p65 activation in pancreatic cancer in vitro and in vivo. BMC Cancer. 2009 Nov 13;9:395. doi: 10.1186/1471-2407-9-395.
  • Loos M, Hedderich DM, Ottenhausen M, Giese NA, Laschinger M, Esposito I, Kleeff J, Friess H. Expression of the costimulatory molecule B7-H3 is associated with prolonged survival in human pancreatic cancer. BMC Cancer. 2009 Dec 26;9:463. doi: 10.1186/1471-2407-9-463.
  • Shepherd TM, Thelwall PE, Stanisz GJ, Blackband SJ. Aldehyde fixative solutions alter the water relaxation and diffusion properties of nervous tissue. Magn Reson Med. 2009 Jul;62(1):26-34. doi: 10.1002/mrm.21977.
  • Yong-Hing CJ, Obenaus A, Stryker R, Tong K, Sarty GE. Magnetic resonance imaging and mathematical modeling of progressive formalin fixation of the human brain. Magn Reson Med. 2005 Aug;54(2):324-32.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Crocetti, MD,PhD +39 050 99 ext 5551 laura.crocetti@med.unipi.it
Contact: Rosa Cervelli, MD +39 050 99 ext 5551 rosa.cervelli@virgilio.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012021
Other Study ID Numbers  ICMJE 13646
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Crocetti, University of Pisa
Study Sponsor  ICMJE University of Pisa
Collaborators  ICMJE
  • Azienda Ospedaliero, Universitaria Pisana
  • Imago 7
Investigators  ICMJE
Principal Investigator: Laura Crocetti, MD,PhD University of Pisa
PRS Account University of Pisa
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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