MR Compatible Accelerometer for Respiratory MOTion Measurement

Heart Disease Clinical Trial

— MARMOT  

Official title:

MR Compatible Accelerometer for Respiratory MOTion Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894632
• Other study ID #: 2012-A00874-39
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: September 5, 2016
• Start date: July 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Device:
• MRI compatible motion sensor (MARMOT)
MRI with motion control (several motion sensors placed on the volunteer's body)

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy Brabois	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	four months	No
Primary	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.	four months	No
Primary	Respiratory movement using real-time MR images	Motion measurement (in mm) directly on the MR images (using real-time MR imaging)	four months	No
Secondary	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.	four months	No