Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04012021
Acronym
EXLIPSE
Enrollment
30
Registered
2019-07-09
Start date
2019-05-24
Completion date
2020-12-31
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

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

Sponsors

Azienda Ospedaliero, Universitaria Pisana
CollaboratorOTHER
Imago 7
CollaboratorOTHER
University of Pisa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Three single groups to be included

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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 lesions3 yearsThe 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.

Countries

Italy

Contacts

Primary ContactLaura Crocetti, MD,PhD
laura.crocetti@med.unipi.it+39 050 99
Backup ContactRosa Cervelli, MD
rosa.cervelli@virgilio.it+39 050 99

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026