Assessment of Portal Hypertension With Multiparametric MRI

Portal Hypertension Clinical Trial

Official title:

Assessment of Portal Hypertension With Multiparametric MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436550
• Other study ID #: GCO 16-1307
• Secondary ID: 1R01DK113272-01A
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: July 19, 2022

Study information

• Verified date: March 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinically Significant Portal Hypertension
• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Procedure:
• mpMRI
Multiparametric MRI
• ARFI US
Acoustic radiation force impulse is a type of ultrasound elastography

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of prediction of hepatic decompensation	Prospective 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.	Within 12 months of initial index MRI
Secondary	Degree of ascites and TIPS patency	Predicting 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.	3-6 months after TIPS procedure or beta-blockers have been prescribed