Status:

COMPLETED

Assessment of Portal Hypertension With Multiparametric MRI

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Portal Hypertension

Clinically Significant Portal Hypertension

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this study is to determine whether new multiparametric magnetic resonance imaging (MRI) methods (including diffusion-weighted MRI, dynamic contrast-enhanced MRI, MR elastography and pha...

Detailed Description

Liver cirrhosis has been historically classified as a single histopathologic entity, as it is considered to be the latest fibrosis stage; however it is well known that cirrhosis encompasses different ...

Eligibility Criteria

Inclusion

  • Chronic liver disease (including all etiologies of liver disease)
  • 18 years of age and older
  • Patient is able to give informed consent for this study
  • Patients preferably (but not necessarily) underwent/will undergo:
  • Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as part of routine clinical care and/or HVPG measurement as part of their clinical care (within 6 months) and/or clinically indicated upper gastrointestinal endoscopy.
  • and/or
  • Liver transplant or liver resection performed as part of routine clinical care and/or
  • Medical therapy for portal hypertension or TIPS placement as part of routine clinical care.
  • Control group
  • Healthy volunteers without history of liver disease (will be used for the purpose of image optimization). These subjects will NOT undergo HVPG measurement.
  • 18 years of age and older

Exclusion

  • Age less than 18 years
  • Unable or unwilling to give informed consent
  • Contra-indications to MRI
  • Electrical implants such as cardiac pacemakers or perfusion pumps
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • Ferromagnetic objects such as jewelry or metal clips in clothing
  • Pregnant subjects
  • Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.

Key Trial Info

Start Date :

March 20 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 19 2022

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT03436550

Start Date

March 20 2018

End Date

July 19 2022

Last Update

March 6 2023

Active Locations (1)

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Mount Sinai Medical Center

New York, New York, United States, 10029