MR Compatible Accelerometer for Respiratory MOTion Measurement (MARMOT)

September 5, 2016 updated by: Central Hospital, Nancy, France
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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vandoeuvre-lès-Nancy, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laurent Bonnemains, Dr, Inserm - U947

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

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)?

No

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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