Assessment of Portal Hypertension With Multiparametric MRI

Description

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 phase-contrast imaging) can be useful in assessing liver damage and degree of portal hypertension (a complication of advanced liver fibrosis and cirrhosis) secondary to chronic liver disease, compared to ultrasound measurement of liver stiffness [acoustic radiation force impulse (ARFI) ultrasound] and routine blood tests. MRI uses magnetic fields to look at soft tissues in the body. This study will ultimately help to determine whether these methods will be useful in identifying liver disease and their complications that cannot be well-understood using current liver MRI techniques.

Study Start Date

December, 12 2017

Estimated Completion Date

November 2021

Interventions

  • Procedure: mpMRI
  • Procedure: ARFI US

Study ID

Icahn School of Medicine at Mount Sinai -- GCO 16-1307

Status

Recruiting

Trial ID

NCT03436550

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

186

Sponsor

Icahn School of Medicine at Mount Sinai

Inclusion Criteria

  • 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: 1. 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 2. Liver transplant or liver resection performed as part of routine clinical care and/or 3. 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 Criteria

  • Age less than 18 years
  • Unable or unwilling to give informed consent
  • Contra-indications to MRI 1. Electrical implants such as cardiac pacemakers or perfusion pumps 2. 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 3. Ferromagnetic objects such as jewelry or metal clips in clothing 4. Pregnant subjects 5. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Mount Sinai Medical Center - New York, New York 46.8 miles Courtney Mahr 212-824-8475 courtney.mahr@mountsinai.org

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