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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

Tracking Information
First Submitted Date October 15, 2019
First Posted Date October 18, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of MRI in Detection of Minimal Hepatic Encephalopathy
Official Title Role of Magnetic Resonance Imaging in Detection of Minimal Hepatic Encephalopathy
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Liver Cirrhoses
  • Hepatic Encephalopathy
Intervention 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
Study Groups/Cohorts
  • Minimal Hepatic Encephalopathy
    Patients with hyperammonemia and minimal hepatic encephalopathy
    Intervention: Diagnostic Test: Magnetic Resonance Imaging
  • Control
    Healthy controls
    Intervention: Diagnostic Test: Magnetic Resonance Imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 16, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2023
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Known liver disease/cirrhosis

Exclusion Criteria:

  • Pregnancy, non compatible material with MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Gasper Zupan, M.D. 0038615437826 gasper.zupan@mf.uni-lj.si
Contact: Sebastian Stefanovic, M.D. sebastian.stefanovic@gmail.com
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04131205
Other Study ID Numbers HepaticEncephalopathy
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sebastian Stefanovic, MD, University Medical Centre Ljubljana
Study Sponsor University Medical Centre Ljubljana
Collaborators
  • University of Ljubljana, Faculty of Medicine
  • Medical University of Graz
  • Johns Hopkins University
Investigators
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
PRS Account University Medical Centre Ljubljana
Verification Date October 2019