Portal HypertensionNCT03436550
Assessment of Portal Hypertension With Multiparametric MRI
An observational study of Portal Hypertension and Clinically Significant Portal Hypertension, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension, Clinically Significant Portal Hypertension
- What is being tested?
- mpMRI and ARFI US
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 19 Jul 2022
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mount Sinai patients with concomitant portal pressure measurements and liver biopsy and/or upper GI endoscopy.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
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.
Read the 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.
- Being tested
- mpMRI, ARFI US
- Keywords
- Hepatic Venous Pressure Gradient, Magnetic Resonance Imaging, Acoustic Radiation Force Impulse, Elastography, Ultrasound, Liver Cirrhosis
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRIProcedure or surgery
Multiparametric MRI
ARFI USProcedure or surgery
Acoustic radiation force impulse is a type of ultrasound elastography
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Liver Disease | Not described Receives: Procedure: mpMRI; Procedure: ARFI US | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Within 12 months after initial index MRI
Secondary outcomes (2)
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.
Measured: Within 12 months of initial index MRI
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.
Measured: 3-6 months after TIPS procedure or beta-blockers have been prescribed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Mar 2018
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bachir Taouli, Icahn School of Medicine at Mount Sinai
- Investigators
- Bachir Taouli, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436550
- Sponsor's protocol ID
- GCO 16-1307
- Other IDs
- 1R01DK113272-01A1
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41014103