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Role of MRI in Detection of Minimal Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT04131205
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
University of Ljubljana, Faculty of Medicine
Medical University of Graz
Johns Hopkins University
Information provided by (Responsible Party):
Sebastian Stefanovic, MD, University Medical Centre Ljubljana

Brief Summary:

Introduction Liver cirrhosis (LC) is irreversible fibrosis of the liver (1) and it remains a public health problem. One of the complications of the cirrhosis is hepatic encephalopathy (HE) which is defined as brain dysfunction caused by liver insufficiency. Pathophysiological mechanisms of HE are complex and multifactorial. Recognition of beginning stages of HE, such as minimal HE (mHE) is of most importance.

Objectives and originality of the project Diagnosis of mHE can be challenging, time-consuming and, at least to some extent, subjective. This project will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique. With advanced magnetic resonance (MR) techniques, in-vivo detection of intracellular water content, estimation pH and metabolites levels with millimolar concentrations can be easily performed. This will offer to explore possible pathophysiological mechanisms of HE and to evaluate the results from previous, studies that were mainly performed on animal models or cell cultures.

By our best knowledge, multimodal MR approach as the investigators propose in this application has not been yet performed. The investigators will use advanced MR techniques which are currently not available in the clinical setting and require multicenter collaboration.

Methods The investigators will include 10-20 patients of both genders with hyperammonemia and mHE and 10-20 patients of both genders with HE. Diagnosis of HE will be made based on results of validated neuropsychiatric test. Age-matched and gender-matched control group with no gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the blood. Patients with mHE/HE will be included from outpatient clinic of the Department of gastroenterology, University Medical Centre (UMC) Ljubljana. Healthy controls (HC) will be invited to join via internet advertisement. Contraindications for HC will include gastrointestinal (emphasis on liver disease), neurological or psychiatric complaints. Grade of mHE/HE will be classified according to West-Haven (WH) classification. Patients with different degree of liver cirrhosis, which will be scored with the Child-Pugh (CP) score, and with no contraindications for MR (e.g. presence of metal in body) will be included. Blood levels of liver enzymes and ammonia will be measured in all participants. MR scanning will include: T1- and T2-weighted MR, MRS (MEGA-PRESS and PRESS) in two voxels: striatum and cerebellum. Location will be double-checked by voxel position screenshots. Analysis, with voxel-positioning error compensation will be performed in Gannet (www.gabamrs.com). Moreover, high resolution diffusion weighted imaging (DWI), diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) will be performed in brain as well. Liver QSM will be executed to assess iron load.


Condition or disease Intervention/treatment
Liver Cirrhoses Hepatic Encephalopathy Diagnostic Test: Magnetic Resonance Imaging

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Magnetic Resonance Imaging in Detection of Minimal Hepatic Encephalopathy
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023


Group/Cohort Intervention/treatment
Minimal Hepatic Encephalopathy
Patients with hyperammonemia and minimal hepatic encephalopathy
Diagnostic Test: Magnetic Resonance Imaging
We will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique
Other Names:
  • Ammonia Levels
  • Child Pugh Score
  • West-Haven grade of Hepatic Encephalopathy

Control
Healthy controls
Diagnostic Test: Magnetic Resonance Imaging
We will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique
Other Names:
  • Ammonia Levels
  • Child Pugh Score
  • West-Haven grade of Hepatic Encephalopathy




Primary Outcome Measures :
  1. Structural and Functional Changes in Brain Structures with Magnetic Resonance Imaging [ Time Frame: 2 hours ]
    GABA levels and other neurotransmitters with respect to the tissue water signal and corrected for tissue composition.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We will include 10-20 patients of both genders with signs of hepatic encephalopathy and 10-20 patients of both genders without HE. Diagnosis of HE will be made based on results of validated neuropsychiatric test. Age-matched and gender-matched control group with no gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the blood.
Criteria

Inclusion Criteria:

  • Known liver disease/cirrhosis

Exclusion Criteria:

  • Pregnancy, non compatible material with MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131205


Contacts
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Contact: Gasper Zupan, M.D. 0038615437826 gasper.zupan@mf.uni-lj.si
Contact: Sebastian Stefanovic, M.D. sebastian.stefanovic@gmail.com

Locations
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Slovenia
Department of Gastroenterology and Hepatology, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Sebastian Stefanovic, M.D.    0038615224166    sebastian.stefanovic@gmail.com   
Contact: Marjana Turk Jerovsek, M.D.    0038615224166    marjanca88@gmail.com   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana, Faculty of Medicine
Medical University of Graz
Johns Hopkins University
Investigators
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Study Chair: Dusan Suput, M.D. Medical Faculty of Ljubljana
Study Chair: Borut Stabuc, M.D. Department of Gastroenterology and Hepatology, University Medical Centre Ljubljana

Publications of Results:
Other Publications:

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Responsible Party: Sebastian Stefanovic, MD, Clinical Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04131205    
Other Study ID Numbers: HepaticEncephalopathy
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases