Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor (g-BrainMRE)
Primary Purpose
Elasticity Imaging Techniques
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Device for mechanical excitation by pressure waves
Sponsored by
About this trial
This is an interventional diagnostic trial for Elasticity Imaging Techniques
Eligibility Criteria
Inclusion Criteria for healthy subjects will be:
- Age between 18 and 65 years
- Ability to hold in an MRI device without moving
- No known and diagnosed neurological pathologies such as stroke, cerebral surgery, central nervous system tumor, inflammatory disease (such as multiple sclerosis), neurodegenerative disease (such as Alzheimer's, Parkinson's or Creutzfeldt-Jakobes's ), depression
- Informed consent
Inclusion criteria for patients will be:
- Age between 18 and 65 years
- Ability to hold in an MRI device without moving
- Glial tumor greater than 3 mm diagnosed by standard MRI
- Informed and informed consent
Exclusion Criteriafor both patients and healthy subjects will be:
Inability to perform an MRI examination : claustrophobia, presence of ferromagnetic metallic foreign bodies, wearing a pace-maker, metallic cardiac prosthetic valve, cochlear implants, vascular clips, insulin pump, pregnancy, breastfeeding..
- Non-affiliation to a social security scheme (beneficiary or beneficiary)
- Intercurrent disorder likely to disrupt test results
- Patient under anticoagulant:
Sites / Locations
- Denis DUCREUXRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Examination of cerebral MRI elastography
Arm Description
The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI
Outcomes
Primary Outcome Measures
normal values of cerebral MRI elastography in healthy volunteers
Mechanical excitation by pressure waves
Secondary Outcome Measures
Values of shear modulus of elasticity in the brain region explored
Mechanical excitation by pressure waves
Values of shear viscosity modulus according to the explored region of the brain
Mechanical excitation by pressure waves
Full Information
NCT ID
NCT03274037
First Posted
September 4, 2017
Last Updated
September 7, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03274037
Brief Title
Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor
Acronym
g-BrainMRE
Official Title
The Relevance of Cerebral MRI Elastography in the Mechanical Characterization of Glial Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
July 7, 2020 (Anticipated)
Study Completion Date
July 7, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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
MRI elastography detects the movement of tissues in the human body and monitors their response to mechanical stress in order to reveal their mechanical properties, like palpation. These depend on the structure of the tissues, their biological conditions and possible conditions. This non-invasive technique allows exploration of deep organs such as the brain that the doctor's hand can not reach. MRI elastography may prove to be an essential tool for study, diagnosis, staging and therapeutic monitoring of brain diseases.
Neurodegenerative diseases (Alzheimer's, Parkinson's, Creutzfeldt-Jakobes) and cancers largely modify the mechanical properties of the affected tissues. For a first evaluation of the technique, we are interested in glial tumors representing half of the intracranial tumors in adults (incidence: 5 cases per 100 000 inhabitants), the second cancer in children and the third cause of death in l Young adult.
Detailed Description
Initiated in 1996, magnetic resonance elastography detects the movement of tissues in the human body and monitors their response to mechanical stress in order to reveal their mechanical properties. These depend on the structure of the tissues, their biological conditions and the possible affections affecting them,. This technique, with recognized safety, allows us to replace the doctor's usual palpation of peripheral organs, such as the liver, or the breast, and to consider the exploration of deeper organs such as the heart or the brain ,. At the Bicêtre Inter-Establishment Center, under the direction of Ralph Sinkus of the Beaujon Hospital, the elastography of breast7 (for the exploration of tumors) and of the heart9 is already being studied . At the Hôpital de Beaujon, elastography was developed to study tumors, fibrosis and cirrhosis of the liver5. Through a vibrating bar, Mayo Clinic11, in the United States, then, in an oscillating cradle, Charity12, Germany, induced waves in the human brain and early measurements of the brain's elastography showed a Significant difference in the modulus of elasticity and viscosity of the white matter and the gray matter. The dependence of these modules on age and gender was discussed.
The elasticity measured by MRI of tumors of 38 to 75 mm in diameter could also be correlated with the tissue consistency of the samples obtained during a surgical reduction. Finally, in a patient with a temporal glioma, the mean modulus of elasticity in the tumor region was measured by elastography close to 30% greater than in the corresponding region of the healthy hemisphere.
But the difficulty of introducing a mechanical wave into the brain through the cranial chamber and the surrounding cerebro-spinal fluid limits the scope of the advanced results, which are essentially qualitative at the moment. The median amplitude of the displacements measured in the brain during these studies is only 7.33 μm at 40 Hz and drops to 2.70 μm at 120 Hz while it is more than 21 μm in the Liver and breast at 75 and 90 Hz respectively4. Recently, the IR4M has developed an original excitation device that allows to circumvent this limit. Displacements of cerebral tissues of several tens of micrometers have been reported by MRI and the inversion of the problem leading to the viscoelastic modules could be carried out on the whole of the human brain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elasticity Imaging Techniques
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Examination of cerebral MRI elastography
Arm Type
Experimental
Arm Description
The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
Device for mechanical excitation by pressure waves
Intervention Description
The IRM elastography technique, proven and patented in 2010 by the IR4M (Orsay, France), consists in characterizing by IRM induced waves in the human body in order to determine the mechanical properties Of the target organ.
The mechanical waves will be induced by pressure waves guided at the mouth of the subject elongated in the MRI and consisting of a function generator at a frequency between 5 Hz and 500 Hz, linear amplifier , An electromechanical transducer, a waveguide whose length is adapted to the chosen excitation frequency, an antibacterial filter and a disposable mouthpiece
The MRI imager Achieva 1.5 T MRI (Philips Healthcare, Best, the Netherlands) and the SIGNA Architect GEM 3.0T (GE medical systems, LLC, USA) system will be used to measure brain tissue displacement fields.
Primary Outcome Measure Information:
Title
normal values of cerebral MRI elastography in healthy volunteers
Description
Mechanical excitation by pressure waves
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Values of shear modulus of elasticity in the brain region explored
Description
Mechanical excitation by pressure waves
Time Frame
1 month
Title
Values of shear viscosity modulus according to the explored region of the brain
Description
Mechanical excitation by pressure waves
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for healthy subjects will be:
Age between 18 and 65 years
Ability to hold in an MRI device without moving
No known and diagnosed neurological pathologies such as stroke, cerebral surgery, central nervous system tumor, inflammatory disease (such as multiple sclerosis), neurodegenerative disease (such as Alzheimer's, Parkinson's or Creutzfeldt-Jakobes's ), depression
Informed consent
Inclusion criteria for patients will be:
Age between 18 and 65 years
Ability to hold in an MRI device without moving
Glial tumor greater than 3 mm diagnosed by standard MRI
Informed and informed consent
Exclusion Criteriafor both patients and healthy subjects will be:
Inability to perform an MRI examination : claustrophobia, presence of ferromagnetic metallic foreign bodies, wearing a pace-maker, metallic cardiac prosthetic valve, cochlear implants, vascular clips, insulin pump, pregnancy, breastfeeding..
Non-affiliation to a social security scheme (beneficiary or beneficiary)
Intercurrent disorder likely to disrupt test results
Patient under anticoagulant:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis MD DUCREUX, PhD
Phone
01 45 21 33 88
Email
denis.ducreux@bct.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier MD MAITRE, PhD
Phone
01 69 15 41 34
Email
xavier.maitre@u-psud.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis MD DUCREUX, PhD
Organizational Affiliation
Assistance publique des hopitaux de paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denis DUCREUX
City
Kremlin BICETRE
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis MD DUCREUX, PhD
Phone
01 45 21 33 88
Email
denis.ducreux@bct.aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor
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