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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Elasticity Imaging Techniques

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 4, 2017
Last Updated
September 7, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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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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