MRE-IA in Liver Disease and Neurovascular Imaging

NCT03601845 | Completed

• 1 other identifier: MEO-31-2019-7773
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Diffuse and Focal Liver Diseases, Cerebral Function

Keywords

Magnetic resonance elastography; Intrinsic activation; Liver disease; Cerebral function

Outcome Measures

Primary Outcomes (6)

• Elasticity of brain

  Measure of elasticity of brain using iMRE

  1 day During scheduled brain iMRE examination

• Viscosity of brain

  Measure of viscosity of brain using iMRE

  1 day During scheduled brain iMRE examination

• Porosity of brain

  Measure of porosity of brain using iMRE

  1 day During scheduled brain iMRE examination

• Elasticity of liver

  Measure of elasticity of liver using iMRE

  1 day During scheduled brain iMRE examination

• Viscosity of liver

  Measure of viscosity of liver using iMRE

  1 day During scheduled brain iMRE examination

• Porosity of liver

  Measure of porosity of liver using iMRE

  1 day During scheduled brain iMRE examination

Secondary Outcomes (4)

• Correlation between measures of poroviscoelasticity parameters of liver and histopathological features

  1 day During scheduled brain iMRE examination

• Repeatability of elasticity of liver

  1 day During scheduled brain iMRE examination

• Repeatability of viscosity of liver

  1 day During scheduled brain iMRE examination

• Repeatability of porosity of liver

  1 day During scheduled brain iMRE examination

Study Arms (2)

MRE-IA (no stimuli)

OTHER

Additional sequencing only

Other: No stimuli

MRE-IA with stimuli

ACTIVE COMPARATOR

Visual stimulation while using additional sequencing

Other: Stimuli

Interventions

Stimuli OTHER

Visual stimulation while using additional sequencing

MRE-IA with stimuli

No stimuli OTHER

Additional sequencing only

MRE-IA (no stimuli)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Réseau de bio-imagerie du Québec (RBIQ): collaborator

Study Sites (2)

CRCHUM

Montreal, Quebec, H2X0C1, Canada

Location

CRCHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Stimuli Responsive Polymers

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Smart Materials; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Van Houten Elijah, Ing., PhD

  Centre hospitalier de l'Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Additional sequences during magnetic resonance elastography by intrinsic activation with or without stimuli

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 26, 2018
• Study Start: January 31, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

CA (2)