Diffuse and Focal Liver Diseases, Cerebral FunctionMRE-IANCT03601845
MRE-IA in Liver Disease and Neurovascular Imaging
A study testing Stimuli and No stimuli in people with Diffuse and Focal Liver Diseases, Cerebral Function, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diffuse and Focal Liver Diseases, Cerebral Function
- What is being tested?
- Stimuli and No stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesCanada
- Study dates
- 31 Jan 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CRCHUM
Montreal, Quebec, H2X0C1
CRCHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Magnetic Resonance Elastography by Intrinsic Activation in Liver Disease and Neurovascular Imaging
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.
Read the 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.
- Being tested
- Stimuli, No stimuli
- Keywords
- Magnetic resonance elastography, Intrinsic activation, Liver disease, Cerebral function
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimuliOther
Visual stimulation while using additional sequencing
No stimuliOther
Additional sequencing only
| Study group | Role | What they receive |
|---|---|---|
| MRE-IA (no stimuli) | Other | Additional sequencing only Receives: Other: No stimuli |
| MRE-IA with stimuli | Active comparator | Visual stimulation while using additional sequencing Receives: Other: Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity of brain
Measure of elasticity of brain using iMRE
Measured: 1 day During scheduled brain iMRE examination
Viscosity of brain
Measure of viscosity of brain using iMRE
Measured: 1 day During scheduled brain iMRE examination
Porosity of brain
Measure of porosity of brain using iMRE
Measured: 1 day During scheduled brain iMRE examination
Elasticity of liver
Measure of elasticity of liver using iMRE
Measured: 1 day During scheduled brain iMRE examination
Viscosity of liver
Measure of viscosity of liver using iMRE
Measured: 1 day During scheduled brain iMRE examination
Porosity of liver
Measure of porosity of liver using iMRE
Measured: 1 day During scheduled brain iMRE examination
Secondary outcomes (4)
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
Measured: 1 day During scheduled brain iMRE examination
Repeatability of elasticity of liver
Measure of repeatability of elasticity of liver using iMRE
Measured: 1 day During scheduled brain iMRE examination
Repeatability of viscosity of liver
Measure of repeatability of viscosity of liver using iMRE
Measured: 1 day During scheduled brain iMRE examination
Repeatability of porosity of liver
Measure of repeatability of porosity of liver
Measured: 1 day During scheduled brain iMRE examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start31 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse and Focal Liver Diseases, Cerebral FunctionStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Additional sequences during magnetic resonance elastography by intrinsic activation with or without stimuli
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Réseau de bio-imagerie du Québec (RBIQ)
- Responsible party
- Sponsor
- Investigators
- Van Houten Elijah, Ing., PhD, Principal investigator, Centre hospitalier de l'Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601845
- Sponsor's protocol ID
- MEO-31-2019-7773
- Acronym
- MRE-IA
- Status last verified
- Feb 2020
- First submitted
- 18 Jun 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography by Intrinsic Activation in Liver Disease and Neurovascular Imaging
- ClinicalTrials.gov ID
- NCT03601845
- Acronym / sponsor ID
- MRE-IA / MEO-31-2019-7773
- Keywords
- Magnetic resonance elastography, Intrinsic activation, Liver disease, Cerebral function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Réseau de bio-imagerie du Québec (RBIQ)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Additional sequences during magnetic resonance elastography by intrinsic activation with or without stimuli
| Arm | Type | Receives |
|---|---|---|
| MRE-IA (no stimuli) | Other | Other: No stimuliAdditional sequencing only |
| MRE-IA with stimuli | Active comparator | Other: StimuliVisual stimulation while using additional sequencing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimuliVisual stimulation while using additional sequencing | Other | MRE-IA with stimuli |
| No stimuliAdditional sequencing only | Other | MRE-IA (no stimuli) |
Primary outcome
Elasticity of brain
Time frame: 1 day During scheduled brain iMRE examination
Measure of elasticity of brain using iMRE
Viscosity of brain
Time frame: 1 day During scheduled brain iMRE examination
Measure of viscosity of brain using iMRE
Porosity of brain
Time frame: 1 day During scheduled brain iMRE examination
Measure of porosity of brain using iMRE
Elasticity of liver
Time frame: 1 day During scheduled brain iMRE examination
Measure of elasticity of liver using iMRE
Viscosity of liver
Time frame: 1 day During scheduled brain iMRE examination
Measure of viscosity of liver using iMRE
Porosity of liver
Time frame: 1 day During scheduled brain iMRE examination
Measure of porosity of liver using iMRE
4 secondary outcomes
Correlation between measures of poroviscoelasticity parameters of liver and histopathological features
Time frame: 1 day During scheduled brain iMRE examination
Repeatability of elasticity of liver
Time frame: 1 day During scheduled brain iMRE examination
Repeatability of viscosity of liver
Time frame: 1 day During scheduled brain iMRE examination
Repeatability of porosity of liver
Time frame: 1 day During scheduled brain iMRE examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Houten Elijah, Ing., PhD principal investigator
Centre hospitalier de l'Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimuli and No stimuli in people with Diffuse and Focal Liver Diseases, Cerebral Function, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity of brain (time frame: 1 day During scheduled brain iMRE examination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.