Heart DiseaseMARMOTNCT02894632
MR Compatible Accelerometer for Respiratory MOTion Measurement
A study testing MRI compatible motion sensor (MARMOT) in people with Heart Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- MRI compatible motion sensor (MARMOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Aug 2016
- 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
- To not have cardiac, hepatic or renal pathology
- To be more than 18
- To be enrolled in a social security plan
- To have signed an informed consent
- To have preliminary medical examination
Who cannot join
- Contraindication: implantable devices (pacemakers, defibrillators, cochlear implants, etc.), metallic foreign bodies
- Impossibility to undergo MRI : claustrophobia, morbid obesity
- Pregnancy or risk of pregnancy
- Patient under a measure of legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire de Nancy Brabois
Vandœuvre-lès-Nancy, 54511
About this study
A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation.
Read the detailed description
Respiratory motion is a serious problem in the acquisition of high-quality thoracic/abdominal magnetic resonance (MR) images. Various methods have been proposed to compensate the motion-induced artefacts, including breathholding, respiratory gating and model-driven motion correction.
Breath-holding is the simplest among the three. However this conventional clinical method induces various problem, including inefficient use of scanners, inconsistent organ position between each breath-hold, imaging an altered physiological status and patient inconvenience especially for those who suffer from respiration difficulties. Free-breathing MR acquisition has therefore become of great clinical interest recently.
The investigators intend to examine the efficacy of the MARMOT sensors for:
- modelling and predicting the respiratory motions in abdominal scans,
- correcting for the respiratory motion in a cardiac cine scan, via a reconstruction-based method.
- Conditions
- Heart Disease
- Being tested
- MRI compatible motion sensor (MARMOT)
- Keywords
- MRI, Motion, Respiratory movement, Artifacts correction
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI compatible motion sensor (MARMOT)Device
MRI with motion control (several motion sensors placed on the volunteer's body)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Volunteers without cardiac, hepatic or renal pathology Receives: Device: MRI compatible motion sensor (MARMOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory movement using respiratory belts
Respiratory belts, which are usually used in MRI to monitor respiratory movements and brath-holding, are placed around the volunteer's body (on the abdominal and on the thoracic level).
They give the average displacement (in mm) across time generated by the respiratory movement.
Measured: four months
Respiratory movement using MARMOT sensors
MARMOT sensors are placed on the volunteer's body (4 sensors placed on the thorax or on the abdomen).
MARMOT sensors give 2 measures : acceleration generated by the respiratory movement (in mm/s²) in 3 directions and rotation generated by the respiratory movement (angle in °/s) in 3 directions.
Measured: four months
Respiratory movement using real-time MR images
Motion measurement (in mm) directly on the MR images (using real-time MR imaging)
Measured: four months
Secondary outcomes (1)
Subjective quality (marks between 1 (the best) and 3 (the worst) of the reconstructed MR images)
Comparing the quality of the reconstructed cardiac cine images obtained with the cine-GRICS algorithm using:
- the pneumatic belts alone
- all MARMOT signals
- signals from only one MARMOT sensor.
Three cardiologists are shown with the motion-compensated cine movies obtained using these three sensor configurations. The movies are presented in random ordering on the screen so that the clinicians are blind to the sensor configuration. They are then asked to rank them by overall image quality (1=best, 2=second best, 3=worst). Equal quality ranking is allowed in this procedure.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Bonnemains, Dr, Principal investigator, Inserm - U947
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894632
- Sponsor's protocol ID
- 2012-A00874-39
- Acronym
- MARMOT
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Compatible Accelerometer for Respiratory MOTion Measurement
- ClinicalTrials.gov ID
- NCT02894632
- Acronym / sponsor ID
- MARMOT / 2012-A00874-39
- Conditions
- Heart Disease
- Keywords
- MRI, Motion, Respiratory movement, Artifacts correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation.
Detailed description
Respiratory motion is a serious problem in the acquisition of high-quality thoracic/abdominal magnetic resonance (MR) images. Various methods have been proposed to compensate the motion-induced artefacts, including breathholding, respiratory gating and model-driven motion correction.
Breath-holding is the simplest among the three. However this conventional clinical method induces various problem, including inefficient use of scanners, inconsistent organ position between each breath-hold, imaging an altered physiological status and patient inconvenience especially for those who suffer from respiration difficulties. Free-breathing MR acquisition has therefore become of great clinical interest recently.
The investigators intend to examine the efficacy of the MARMOT sensors for:
- modelling and predicting the respiratory motions in abdominal scans,
- correcting for the respiratory motion in a cardiac cine scan, via a reconstruction-based method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: MRI compatible motion sensor (MARMOT)Volunteers without cardiac, hepatic or renal pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To not have cardiac, hepatic or renal pathology
- To be more than 18
- To be enrolled in a social security plan
- To have signed an informed consent
- To have preliminary medical examination
Key exclusion criteria (4 listed)
- Contraindication: implantable devices (pacemakers, defibrillators, cochlear implants, etc.), metallic foreign bodies
- Impossibility to undergo MRI : claustrophobia, morbid obesity
- Pregnancy or risk of pregnancy
- Patient under a measure of legal protection
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 |
|---|---|---|
| MRI compatible motion sensor (MARMOT)MRI with motion control (several motion sensors placed on the volunteer's body) | Device | Healthy volunteers |
Primary outcome
Respiratory movement using respiratory belts
Time frame: four months
Respiratory belts, which are usually used in MRI to monitor respiratory movements and brath-holding, are placed around the volunteer's body (on the abdominal and on the thoracic level). They give the average displacement (in mm) across time generated by the respiratory movement.
Respiratory movement using MARMOT sensors
Time frame: four months
MARMOT sensors are placed on the volunteer's body (4 sensors placed on the thorax or on the abdomen). MARMOT sensors give 2 measures : acceleration generated by the respiratory movement (in mm/s²) in 3 directions and rotation generated by the respiratory movement (angle in °/s) in 3 directions.
Respiratory movement using real-time MR images
Time frame: four months
Motion measurement (in mm) directly on the MR images (using real-time MR imaging)
1 secondary outcome
Subjective quality (marks between 1 (the best) and 3 (the worst) of the reconstructed MR images)
Time frame: four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Laurent Bonnemains, Dr principal investigator
Inserm - U947
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 compatible motion sensor (MARMOT) in people with Heart Disease, run by Central Hospital, Nancy, France 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 4 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: finished, as of the sponsor's last update on 9 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory movement using respiratory belts (time frame: four months). The study lists 3 primary outcomes in all. 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 9 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.