EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI
NCT ID: NCT04012021
Last Updated: 2019-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-05-24
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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
7T Magnetic Resonance Imaging
* T1-weighted and T2-weighted sequences
* quantitative magnetic resonance imaging approach
* proton spectrum analyses
Interventions
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7T Magnetic Resonance Imaging
* T1-weighted and T2-weighted sequences
* quantitative magnetic resonance imaging approach
* proton spectrum analyses
Eligibility Criteria
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Inclusion Criteria
* 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.
\- liver grafts with histologically proven macrovescic steatosis, not fit for transplantation
* 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 liver transplantation.
GROUP B of Excluded Grafts
* 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
\- excluded from surgery due to the severity of their condition.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero, Universitaria Pisana
OTHER
Imago 7
OTHER
University of Pisa
OTHER
Responsible Party
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Laura Crocetti
Associate Professor
Principal Investigators
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Laura Crocetti, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Locations
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Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Kraff O, Fischer A, Nagel AM, Monninghoff 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.
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, Bednarik P, Eberly LE, Oz 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.
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.
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.
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.
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.
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.
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. doi: 10.1053/jlts.2002.34923.
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.
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.
Lehmann A, Denkert C, Budczies J, Buckendahl AC, Darb-Esfahani S, Noske A, Muller 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. doi: 10.1002/mrm.20578.
Other Identifiers
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13646
Identifier Type: -
Identifier Source: org_study_id
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