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

Pancreatic Cancer Clinical Trial

— EXLIPSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012021
• Other study ID #: 13646
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: University of Pisa
• Contact: Laura Crocetti, MD,PhD
• Phone: +39 050 99
• Email: laura.crocetti[@]med.unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Fatty Liver
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Steatosis
• Magnetic Resonance Imaging
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• 7T Magnetic Resonance Imaging
T1-weighted and T2-weighted sequences quantitative magnetic resonance imaging approach proton spectrum analyses

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	PI

Sponsors (3)

Lead Sponsor	Collaborator
University of Pisa	Azienda Ospedaliero, Universitaria Pisana, Imago 7

Country where clinical trial is conducted

Italy, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Terpstra M, Cheong I, Lyu T, Deelchand DK, Emir UE, Bednarík 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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