Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor

NCT ID: NCT03274037

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2020-07-07

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

Conditions

Elasticity Imaging Techniques

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Examination of cerebral MRI elastography

The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI

Group Type: EXPERIMENTAL

Device for mechanical excitation by pressure waves

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Device for mechanical excitation by pressure waves

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• 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 Criteria

• 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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis MD DUCREUX, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance publique des hopitaux de paris

Locations

Denis DUCREUX

Le Kremlin-Bicêtre, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Denis MD DUCREUX, PhD

Role: CONTACT

denis.ducreux@bct.aphp.fr

01 45 21 33 88

Xavier MD MAITRE, PhD

Role: CONTACT

xavier.maitre@u-psud.fr

01 69 15 41 34

Facility Contacts

Denis MD DUCREUX, PhD

Role: primary

denis.ducreux@bct.aphp.fr

01 45 21 33 88

Other Identifiers

IDRCB: 2013-A00289-36

Identifier Type: -

Identifier Source: org_study_id