- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894632
MR Compatible Accelerometer for Respiratory MOTion Measurement (MARMOT)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre-lès-Nancy, France, 54511
- Centre Hospitalier Régional Universitaire de Nancy Brabois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy volunteers
Volunteers without cardiac, hepatic or renal pathology
|
MRI with motion control (several motion sensors placed on the volunteer's body)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
four months
|
|
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. |
four months
|
|
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)
|
four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective quality (marks between 1 (the best) and 3 (the worst) of the reconstructed MR images)
Time Frame: four months
|
Comparing the quality of the reconstructed cardiac cine images obtained with the cine-GRICS algorithm using:
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. |
four months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurent Bonnemains, Dr, Inserm - U947
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-A00874-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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