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Completed

NCT Number: NCT02894632

MR Compatible Accelerometer for Respiratory MOTion Measurement

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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI compatible motion sensor (MARMOT)

Device

MRI with motion control (several motion sensors placed on the volunteer's body)

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Secondary outcomes

  1. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: MARMOT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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