Assessment of Portal Hypertension With Multiparametric MRI

NCT03436550 | Completed DMC

• 2 other identifiers: GCO 16-13071R01DK113272-01A1
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Portal Hypertension; Clinically Significant Portal Hypertension

Keywords

Hepatic Venous Pressure Gradient; Magnetic Resonance Imaging; Acoustic Radiation Force Impulse; Elastography; Ultrasound; Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Rate of diagnosis of portal hypertension (PH)

  Prospective diagnostic performance of mpMRI vs. ARFI US vs. routine serum markers for diagnosis of PH. Diagnosis of PH defined by HVPG ≥5 mmHg

  Within 12 months after initial index MRI

• Rate of diagnosis of clinically significant portal hypertension (CSPH)

  Prospective diagnostic performance of mpMRI vs. ARFI US vs. routine serum markers for diagnosis of CSPH. Diagnosis of CSPH (HVPG ≥10 mmHg)

  Within 12 months after initial index MRI

Secondary Outcomes (2)

• Rate of prediction of hepatic decompensation

  Within 12 months of initial index MRI

• Degree of ascites and TIPS patency

  3-6 months after TIPS procedure or beta-blockers have been prescribed

Study Arms (2)

Patients with Chronic Liver Disease

Procedure: mpMRI; Procedure: ARFI US

Control Group

Interventions

mpMRI PROCEDURE

Multiparametric MRI

Patients with Chronic Liver Disease

ARFI US PROCEDURE

Acoustic radiation force impulse is a type of ultrasound elastography

Patients with Chronic Liver Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mount Sinai patients with concomitant portal pressure measurements and liver biopsy and/or upper GI endoscopy.

You may qualify if:

• Chronic liver disease (including all etiologies of liver disease)
• 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.
• years of age and older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

• Ozkaya E, Bane O, Bhuiyan E, Geahchan A, Altinmakas E, Hectors SJ, Kennedy P, Abboud G, Pavuluri S, Ehman RL, Yin M, Lewis S, Bansal MB, Fischman A, Thung S, Schiano TD, Taouli B. Multiparametric MRI for Diagnosing Clinically Significant Portal Hypertension and Predicting Liver Decompensation. Liver Int. 2025 Nov;45(11):e70368. doi: 10.1111/liv.70368.

  PMID: 41014103 DERIVED

MeSH Terms

Conditions

Hypertension, Portal; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bachir Taouli, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: March 20, 2018
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

US (1)