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Liver CirrhosisEXLIPSENCT04012021

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

A study testing 7T Magnetic Resonance Imaging in people with Liver Cirrhosis and Liver Steatosis, run by University of Pisa at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
7T Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
24 May 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • patients affected by polycystic liver disease
  • 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.

Trial locations and contacts

1 site in 1 country.

Laura Crocetti, MD,PhD contact

+39 050 99 ext. 5551

laura.crocetti@med.unipi.it

Rosa Cervelli, MD contact

+39 050 99 ext. 5551

rosa.cervelli@virgilio.it

Italy1 site, 1 recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI, 56124

    Laura Crocetti, MD, PhD, +39 050 99 ext. 5551, laura.crocetti@med.unipi.it

    Rosa Cervelli, MD, + 39 050 99 ext. 5551, rosa.cervelli@virgilio.it

    Recruiting

Other trials in Italy

About this study

Official title: 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).

Being tested
7T Magnetic Resonance Imaging
Keywords
liver, cirrhosis, steatosis, hepatocellular carcinoma, pancreatic cancer, 7 tesla, magnetic resonance imaging
Medical subject headings
Liver Cirrhosis, Fatty Liver, Carcinoma, Hepatocellular, Pancreatic Neoplasms, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7T Magnetic Resonance ImagingDiagnostic test

    • T1-weighted and T2-weighted sequences
    • quantitative magnetic resonance imaging approach
    • proton spectrum analyses
Study groups in NCT04012021
Study groupRoleWhat they receive
EX-VIVO SPECIMENSExperimentalThree 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
Receives: Diagnostic Test: 7T Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start24 May 2019
  3. Primary completion31 Jan 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Three single groups to be included
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012021
Sponsor's protocol ID
13646
Acronym
EXLIPSE
Status last verified
Jul 2019
First submitted
4 Jul 2019
Last updated
9 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24478137

  • 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.

    PubMed 25820458

  • 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.

    PubMed 21532871

  • 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.

    PubMed 26502373

  • 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.

    PubMed 23855291

  • 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.

    PubMed 22760520

  • 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.

    PubMed 20677284

  • 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.

    PubMed 22882201

  • 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.

    PubMed 22499489

  • 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.

    PubMed 18727702

  • 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.

    PubMed 12360427

  • 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.

    PubMed 29359266

  • 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.

    PubMed 8740402

  • 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.

    PubMed 19912635

  • 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.

    PubMed 20035626

Questions about this trial

What is this clinical trial studying?

A study testing 7T Magnetic Resonance Imaging in people with Liver Cirrhosis and Liver Steatosis, run by University of Pisa at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laura Crocetti, MD,PhD (+39 050 99 ext. 5551, laura.crocetti@med.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04012021, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.

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