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Assessment of Portal Hypertension With Multiparametric MRI

Assessment of Portal Hypertension With Multiparametric MRI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03436550
Enrollment
69
Registered
2018-02-19
Start date
2018-03-20
Completion date
2022-07-19
Last updated
2023-03-06

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

Conditions

Clinically Significant Portal Hypertension, Portal Hypertension

Keywords

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

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.

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 degrees of clinical severity. Advanced liver fibrosis and cirrhosis are commonly associated with portal hypertension, which is due to increased hemodynamic resistance of the liver leading to an increase in portal venous pressure. Portal hypertension leads to the development of esophageal varices associated with a high risk of bleeding, ascites and renal dysfunction. The definite diagnosis of portal hypertension is based on the measurement hepatic venous pressure gradient (HVPG), which is an indirect measure of portal pressure. This technique is invasive and not widely available. Portal hypertension may also be associated with a decrease in portal venous flow/velocity due to a higher parenchymal resistance to flow, and an increase in hepatic arterial flow secondary to an arterial buffer response that can be measured with phase-contrast magnetic resonance imaging (MRI). According to the researcher's recent data, the increased vascular pressure observed in portal hypertension affects liver and spleen stiffness as well as other viscoelastic properties measured with advanced 3D MR elastography, which may potentially be used as biomarkers of portal hypertension. In this proposal, the researchers would like to validate noninvasive imaging biomarkers based on a short multiparametric MRI protocol for the quantification of changes in viscoelastic properties and flow metrics in the liver and spleen in relation to portal hypertension. This protocol could potentially be integrated in routine clinical MRI exams, and could significantly reduce the cost of care by decreasing the need for HVPG measurement, upper gastrointestinal endoscopies, and could provide a novel risk stratification scoring system of liver disease and portal hypertension based on MRI. This will be a highly significant progression in patients with liver disease.

Interventions

PROCEDUREmpMRI

Multiparametric MRI

PROCEDUREARFI US

Acoustic radiation force impulse is a type of ultrasound elastography

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of diagnosis of portal hypertension (PH)Within 12 months after initial index MRIProspective diagnostic performance of mpMRI vs. ARFI US vs. routine serum markers for diagnosis of PH. Diagnosis of PH defined by HVPG ≥5 mmHg
Rate of diagnosis of clinically significant portal hypertension (CSPH)Within 12 months after initial index MRIProspective diagnostic performance of mpMRI vs. ARFI US vs. routine serum markers for diagnosis of CSPH. Diagnosis of CSPH (HVPG ≥10 mmHg)

Secondary

MeasureTime frameDescription
Rate of prediction of hepatic decompensationWithin 12 months of initial index MRIProspective diagnostic performance of mpMRI and ARFI US for predicting hepatic decompensation. Rate of prediction of hepatic decompensation, defined as the occurrence of complications such as GI bleeding, encephalopathy, massive ascites (needing repeated paracentesis) or death.
Degree of ascites and TIPS patency3-6 months after TIPS procedure or beta-blockers have been prescribedPredicting response to TIPS (transjugular intrahepatic portosystemic shunt) and/or beta-blockers in patients with liver cirrhosis. Response will be defined on routine contrast-enhanced CT or MRI obtained within 3-6 months after TIPS or beta-blockers to establish the degree of ascites, and TIPS patency.

Countries

United States

Outcome results

None listed

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