MRE-IA in Liver Disease and Neurovascular Imaging (MRE-IA)
Primary Purpose
Diffuse and Focal Liver Diseases, Cerebral Function
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stimuli
No stimuli
Sponsored by

About this trial
This is an interventional diagnostic trial for Diffuse and Focal Liver Diseases, Cerebral Function focused on measuring Magnetic resonance elastography, Intrinsic activation, Liver disease, Cerebral function
Eligibility Criteria
Inclusion Criteria:
- Are at least 18 years old at screening;
- Are able to comprehend and willingness to provide voluntary consent;
- Are able to have a MRI;
- Understand French or English;
At CHUM:
- Healthy volunteers or;
Have a diffuse liver disease (non alcoholic cirrhosis, hepatitis, NASH) and
- Are scheduled for liver biopsy as part of their standard of care
- Are scheduled for a MRI for clinical or research purpose, or;
Have a focal liver lesion (e.g. hemangioma, hepatocellular carcinoma, cholangiocarcinoma, and metastases) and
- Are scheduled for clinical MRI as part of their standard of care for characterization of liver masses
At CHUS:
- Healthy volunteers.
Exclusion Criteria:
- Have a contra-indication for MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
- Are pregnant or trying to become pregnant;
- Have a weight or girth preventing them from entering the MR magnet bore;
- Are unable to understand or unwilling to provide written informed consent for this study.
Sites / Locations
- CRCHUM
- CRCHUS
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
MRE-IA (no stimuli)
MRE-IA with stimuli
Arm Description
Additional sequencing only
Visual stimulation while using additional sequencing
Outcomes
Primary Outcome Measures
Elasticity of brain
Measure of elasticity of brain using iMRE
Viscosity of brain
Measure of viscosity of brain using iMRE
Porosity of brain
Measure of porosity of brain using iMRE
Elasticity of liver
Measure of elasticity of liver using iMRE
Viscosity of liver
Measure of viscosity of liver using iMRE
Porosity of liver
Measure of porosity of liver using iMRE
Secondary Outcome Measures
Correlation between measures of poroviscoelasticity parameters of liver and histopathological features
Measure of correlation between measures of poroviscoelasticity parameters (elasticity, viscosity and porosity) of liver using iMRE and histopathological features graded by ordinal score
Repeatability of elasticity of liver
Measure of repeatability of elasticity of liver using iMRE
Repeatability of viscosity of liver
Measure of repeatability of viscosity of liver using iMRE
Repeatability of porosity of liver
Measure of repeatability of porosity of liver
Full Information
NCT ID
NCT03601845
First Posted
June 18, 2018
Last Updated
February 6, 2020
Sponsor
Université de Sherbrooke
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM), Réseau de bio-imagerie du Québec (RBIQ)
1. Study Identification
Unique Protocol Identification Number
NCT03601845
Brief Title
MRE-IA in Liver Disease and Neurovascular Imaging
Acronym
MRE-IA
Official Title
Magnetic Resonance Elastography by Intrinsic Activation in Liver Disease and Neurovascular Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM), Réseau de bio-imagerie du Québec (RBIQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this research project is to develop Magnetic Resonance Elastography by Intrinsic Activation (MRE-IA) imaging methods at two imaging centers (CRCHUS and CRCHUM) for use in ongoing studies in liver disease and neurovascular imaging. MRE is a developing MR imaging modality that provides detailed maps of tissue's mechanical properties, based on displacement measurements made during the propagation of low amplitude vibrations through the region of interest. MRE-IA uses the pressure pulses of the cardiac cycle to induce the vibrations needed for MRE image reconstruction.
MRE-IA has already been demonstrated based on the use of existing, clinically approved MR imaging sequences, and once this capability has been established at the two centers, initial trials will be done to demonstrate the method's potential in liver and neurovascular imaging. In the case of the liver, this pilot project funding will be used to perform MRE-IA imaging in patients with chronic liver disease and focal liver lesions. Results will be analyzed to establish the relationship between the mechanical properties mentioned above and disease stage. In the neurovascular case, imaging will be conducted under basic visual and motor stimulus conditions in healthy subjects, and results compared non-stimulus control images to determine changes in the above properties based on brain function. In addition, MRE-IA images will be compared with BOLD imaging to investigate the role of fluid conductivity in fMRI results.
Detailed Description
Unlike current MRE methods which require the application of cyclical mechanical excitations with an external driver, MRE-IA is a recently developed MRE modality that uses the naturally occurring cardiac pressure cycle to generate the displacements used for elastic property reconstruction. With no external activation, MRE-IA provides a simple pathway towards in-vivo elastography results that avoids the discomfort, poor coupling, and high attenuation often observed in MRE extrinsic vibration drivers.
Goals: The principal goal of this project is to establish Magnetic Resonance Elastography by Intrinsic Activation (MRE-IA) imaging methods at the imaging centers of the Centre de recherche du centre hospitalier universitaire de Sherbrooke (CRCHUS) and the Centre de recherche du centre hospitalier universitaire de Montréal (CRCHUM). Each imaging center will then focus on separate sub-goals: improving liver disease assessment with MRE-IA (CRCHUM) and evaluating the role of fluid conductivity and changes in elastic properties with mental tasks (CRCHUS).
Hypothesis: There are two main hypotheses underlying this project: (1) that internal activation provides an effective, robust displacement source for MRE image reconstruction that eliminates the problems of discomfort, high attenuation, artefact sensitivity, and low signal to noise associated with traditional extrinsic MRE methods; and (2) that the advanced material property maps provided by MRE-IA, such as viscoelastic damping, poroelastic effects and anisotropy, will lead to better classification and understanding of both diseased and healthy tissue states.
Methods: The image acquisition methodology for this project will be identical at both imaging centers. Intrinsic activation MRE displacement data will be obtained through the use the Q-Flow angiographic sequence available on the Philips 3T systems at both the CRCHUS and CRCHUM.
MRE-IA for diffuse and focal liver disease (CRCHUM): The objective of this study is to demonstrate the feasibility of MRE-IA imaging in the assessment of liver disease. MRE-IA will be performed in three populations (10 healthy volunteers, 25 patients with diffuse liver disease and 10 patients with focal liver lesions)
Intrinsic MRE: MRE-IA images are reconstructed from phase-contrast sequences that are currently available on MRI scanners at CHUM and CHUS. Post-processing of the images with finite element analysis (FEA) mechanical simulations allows calculation of poroviscoelasticity parameters (i.e. porosity, bulk modulus, storage modulus [G'], and loss modulus [G'']). These poroviscoelasticity parameters will be correlated with histopathological markers of disease severity (fibrosis, inflammation, fat) in patients with chronic liver disease and with the final diagnosis (type of liver lesion).
Cerebral function imaging via MRE-IA (CRCHUS): The objective of this study is to investigate the changes in mechanical properties during the performance of mental tasks and the role of inherent fluid conductivity in the BOLD imaging used in fMRI methods. Multiple imaging sessions will be performed to investigate changes to MRE-IA property maps to visual (V1) stimulation. Imaging sessions will be include either V1 (n=6) or non-stimulus (n=3) cases. Each case will include both MRE-IA and fMRI acquisitions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse and Focal Liver Diseases, Cerebral Function
Keywords
Magnetic resonance elastography, Intrinsic activation, Liver disease, Cerebral function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Additional sequences during magnetic resonance elastography by intrinsic activation with or without stimuli
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRE-IA (no stimuli)
Arm Type
Other
Arm Description
Additional sequencing only
Arm Title
MRE-IA with stimuli
Arm Type
Active Comparator
Arm Description
Visual stimulation while using additional sequencing
Intervention Type
Other
Intervention Name(s)
Stimuli
Intervention Description
Visual stimulation while using additional sequencing
Intervention Type
Other
Intervention Name(s)
No stimuli
Intervention Description
Additional sequencing only
Primary Outcome Measure Information:
Title
Elasticity of brain
Description
Measure of elasticity of brain using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Viscosity of brain
Description
Measure of viscosity of brain using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Porosity of brain
Description
Measure of porosity of brain using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Elasticity of liver
Description
Measure of elasticity of liver using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Viscosity of liver
Description
Measure of viscosity of liver using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Porosity of liver
Description
Measure of porosity of liver using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Secondary Outcome Measure Information:
Title
Correlation between measures of poroviscoelasticity parameters of liver and histopathological features
Description
Measure of correlation between measures of poroviscoelasticity parameters (elasticity, viscosity and porosity) of liver using iMRE and histopathological features graded by ordinal score
Time Frame
1 day During scheduled brain iMRE examination
Title
Repeatability of elasticity of liver
Description
Measure of repeatability of elasticity of liver using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Repeatability of viscosity of liver
Description
Measure of repeatability of viscosity of liver using iMRE
Time Frame
1 day During scheduled brain iMRE examination
Title
Repeatability of porosity of liver
Description
Measure of repeatability of porosity of liver
Time Frame
1 day During scheduled brain iMRE examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are at least 18 years old at screening;
Are able to comprehend and willingness to provide voluntary consent;
Are able to have a MRI;
Understand French or English;
At CHUM:
Healthy volunteers or;
Have a diffuse liver disease (non alcoholic cirrhosis, hepatitis, NASH) and
Are scheduled for liver biopsy as part of their standard of care
Are scheduled for a MRI for clinical or research purpose, or;
Have a focal liver lesion (e.g. hemangioma, hepatocellular carcinoma, cholangiocarcinoma, and metastases) and
Are scheduled for clinical MRI as part of their standard of care for characterization of liver masses
At CHUS:
Healthy volunteers.
Exclusion Criteria:
Have a contra-indication for MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
Are pregnant or trying to become pregnant;
Have a weight or girth preventing them from entering the MR magnet bore;
Are unable to understand or unwilling to provide written informed consent for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Van Houten Elijah, Ing., PhD
Organizational Affiliation
Centre hospitalier de l'Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRCHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X0C1
Country
Canada
Facility Name
CRCHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
MRE-IA in Liver Disease and Neurovascular Imaging
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