MRINCT04369755
MR7T-Healthy-PTX : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla
A study testing MRI in people with MRI and PTX, run by Poitiers University Hospital at 1 site in France.
Trial summary
Magnetic resonance imaging (MRI) is a non-invasive imaging modality used in routine clinical practice for clinical diagnosis by visualizing the anatomical structure and in vivo function of certain organs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2020to Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Subject with no MRI contraindications (metallic shine, pacemaker)
- Free subject, without guardianship or curatorship or subordination
- A person affiliated to or beneficiary of a social security scheme.
- Informed and signed consent by the healthy volunteer after clear and fair information about the study
Who cannot join
- Subject with a contraindication to MRI (pregnancy, ocular metallic foreign body (accidental or other shrapnel); pacemaker (cardiac stimulator), implantable defibrillator, non MRI 7.0 T compatible neurostimulator, cochlear implants and generally any irremovably implanted electronic medical device; metallic heart valve, vascular clips formerly implanted on cranial aneurysm), metallic prostheses.
- Healthy volunteers suffering from claustrophobia
- Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
- Persons benefiting from reinforced protection, i.e. minors, pregnant and breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally, patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers, 86000
Rémy GUILLEVIN
About this study
Official title: Pilote Study : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla on Healthy Subject at Poitiers University Hospital
Magnetic resonance imaging (MRI) is a non-invasive imaging modality used in routine clinical practice for clinical diagnosis by visualizing the anatomical structure and in vivo function of certain organs. The development of ultra-high field MRI systems with 7.0-T or higher, gives access to a new field of exploration of the human body by improving the speed of acquisition but also a better signal-to-noise ratio (SNR) and better resolution. In order to fully exploit the potential of these ultra-high field MRI scanners, various technical issues must be adressed. Indeed, the non-uniformity of the transmission field is one of them leading to non-uniform images with spatially varying contrast. Thus the pTX (parallel transmission) mode using multiple transmission channels allows spatial and temporal control over the RF waves.
- Being tested
- MRI
- Keywords
- MRI, PTX, BRAIN, 7 TESLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
A MRI in PTX mode will be done on healthy subject (approx. 90 min of sequences)
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | A MRI on PTX mode will be done on healthy subjects (approx. 90 min of sequences) Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the improvement of the Signal to Noise Ratio (SNR) in parallel transmission mode (pTx) versus without pTx at 7.0 T on different cerebral anatomical regions/structures (central gray nuclei, cerebellum, white matter, cortex).
The main evaluation criterion is the value of the signal-to-noise ratio in a global way but also by a unit comparison approach (voxel to voxel).
It will be a question of linking these variations to the flip angles but also to the probable inhomogeneities of the B1+ field.
Measured: 1 year
Secondary outcomes (2)
Evaluation of the body temperature
Measurement of body temperature in healthy volunteers using a forehead thermometer before and after examination
Measured: 1 year
Evaluation of anxiety before, during and after the MRI
Measurement of the healthy subject's feelings about the exam (anxiety, heat, nausea) using a grid proposed at the end of the exam.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start25 Jun 2020
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369755
- Sponsor's protocol ID
- 2019-A02689-48
- Status last verified
- Jan 2022
- First submitted
- 27 Apr 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilote Study : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla on Healthy Subject at Poitiers University Hospital
- ClinicalTrials.gov ID
- NCT04369755
- Acronym / sponsor ID
- 2019-A02689-48
- Keywords
- MRI, PTX, BRAIN, 7 TESLA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Apr 2020 (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.
Magnetic resonance imaging (MRI) is a non-invasive imaging modality used in routine clinical practice for clinical diagnosis by visualizing the anatomical structure and in vivo function of certain organs. The development of ultra-high field MRI systems with 7.0-T or higher, gives access to a new field of exploration of the human body by improving the speed of acquisition but also a better signal-to-noise ratio (SNR) and better resolution. In order to fully exploit the potential of these ultra-high field MRI scanners, various technical issues must be adressed. Indeed, the non-uniformity of the transmission field is one of them leading to non-uniform images with spatially varying contrast. Thus the pTX (parallel transmission) mode using multiple transmission channels allows spatial and temporal control over the RF waves.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Other: MRIA MRI on PTX mode will be done on healthy subjects (approx. 90 min of sequences) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Subject with no MRI contraindications (metallic shine, pacemaker)
- Free subject, without guardianship or curatorship or subordination
- A person affiliated to or beneficiary of a social security scheme.
- Informed and signed consent by the healthy volunteer after clear and fair information about the study
Key exclusion criteria (5 listed)
- Subject with a contraindication to MRI (pregnancy, ocular metallic foreign body (accidental or other shrapnel); pacemaker (cardiac stimulator), implantable defibrillator, non MRI 7.0 T compatible neurostimulator, cochlear implants and generally any irremovably implanted electronic medical device; metallic heart valve, vascular clips formerly implanted on cranial aneurysm), metallic prostheses.
- Healthy volunteers suffering from claustrophobia
- Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
- Persons benefiting from reinforced protection, i.e. minors, pregnant and breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally, patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
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 |
|---|---|---|
| MRIA MRI in PTX mode will be done on healthy subject (approx. 90 min of sequences) | Other | MRI |
Primary outcome
Evaluate the improvement of the Signal to Noise Ratio (SNR) in parallel transmission mode (pTx) versus without pTx at 7.0 T on different cerebral anatomical regions/structures (central gray nuclei, cerebellum, white matter, cortex).
Time frame: 1 year
The main evaluation criterion is the value of the signal-to-noise ratio in a global way but also by a unit comparison approach (voxel to voxel). It will be a question of linking these variations to the flip angles but also to the probable inhomogeneities of the B1+ field.
2 secondary outcomes
Evaluation of the body temperature
Time frame: 1 year
Evaluation of anxiety before, during and after the MRI
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with MRI and PTX, run by Poitiers University Hospital 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 5 inclusion and 5 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 27 Jan 2022. 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 Rémy GUILLEVIN, Pr (05.49.44.17.91, remy.guillevin@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the improvement of the Signal to Noise Ratio (SNR) in parallel transmission mode (pTx) versus without pTx at 7.0 T on different cerebral anatomical regions/structures (central gray nuclei, cerebellum, white matter, cortex). (time frame: 1 year). 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 27 Jan 2022.