Elasticity Imaging Techniquesg-BrainMRENCT03274037
Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor
A study testing Device for mechanical excitation by pressure waves in people with Elasticity Imaging Techniques, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elasticity Imaging Techniques
- What is being tested?
- Device for mechanical excitation by pressure waves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2017to 7 Jul 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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:
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Denis DUCREUX
Le Kremlin-Bicêtre, France
Denis MD DUCREUX, PhD, 01 45 21 33 88, denis.ducreux@bct.aphp.fr
About this study
Official title: The Relevance of Cerebral MRI Elastography in the Mechanical Characterization of Glial Tumors
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.
Read the 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
- Being tested
- Device for mechanical excitation by pressure waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device for mechanical excitation by pressure wavesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Examination of cerebral MRI elastography | Experimental | The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI Receives: Diagnostic Test: Device for mechanical excitation by pressure waves |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal values of cerebral MRI elastography in healthy volunteers
Mechanical excitation by pressure waves
Measured: 1 month
Secondary outcomes (2)
Values of shear modulus of elasticity in the brain region explored
Mechanical excitation by pressure waves
Measured: 1 month
Values of shear viscosity modulus according to the explored region of the brain
Mechanical excitation by pressure waves
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start7 Jul 2017
- Primary completion7 Jul 2020 (estimated)
- Study completion7 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elasticity Imaging TechniquesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis MD DUCREUX, PhD, Principal investigator, Assistance publique des hopitaux de paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274037
- Sponsor's protocol ID
- IDRCB: 2013-A00289-36
- Acronym
- g-BrainMRE
- Status last verified
- Jul 2017
- First submitted
- 4 Sep 2017
- Last updated
- 8 Sep 2017
- 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 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance of Cerebral MRI Elastography in the Mechanical Characterization of Glial Tumors
- ClinicalTrials.gov ID
- NCT03274037
- Acronym / sponsor ID
- g-BrainMRE / IDRCB: 2013-A00289-36
- Conditions
- Elasticity Imaging Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 7 Jul 2020 (estimated)
- Study completion
- 7 Jul 2020 (estimated)
- First posted
- 6 Sep 2017 (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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Examination of cerebral MRI elastography | Experimental | Diagnostic Test: Device for mechanical excitation by pressure wavesThe mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Device for mechanical excitation by pressure wavesThe 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. | Diagnostic test | Examination of cerebral MRI elastography |
Primary outcome
normal values of cerebral MRI elastography in healthy volunteers
Time frame: 1 month
Mechanical excitation by pressure waves
2 secondary outcomes
Values of shear modulus of elasticity in the brain region explored
Time frame: 1 month
Values of shear viscosity modulus according to the explored region of the brain
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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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.
Denis MD DUCREUX, PhD principal investigator
Assistance publique des hopitaux de paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device for mechanical excitation by pressure waves in people with Elasticity Imaging Techniques, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 0 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis MD DUCREUX, PhD (01 45 21 33 88, denis.ducreux@bct.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal values of cerebral MRI elastography in healthy volunteers (time frame: 1 month). 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 8 Sep 2017.