Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT02894632
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2016-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MR Compatible Accelerometer for Respiratory MOTion Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-05', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-09-05', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory movement using respiratory belts', 'timeFrame': 'four months', 'description': "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).\n\nThey give the average displacement (in mm) across time generated by the respiratory movement."}, {'measure': 'Respiratory movement using MARMOT sensors', 'timeFrame': 'four months', 'description': "MARMOT sensors are placed on the volunteer's body (4 sensors placed on the thorax or on the abdomen).\n\nMARMOT 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."}, {'measure': 'Respiratory movement using real-time MR images', 'timeFrame': 'four months', 'description': 'Motion measurement (in mm) directly on the MR images (using real-time MR imaging)'}], 'secondaryOutcomes': [{'measure': 'Subjective quality (marks between 1 (the best) and 3 (the worst) of the reconstructed MR images)', 'timeFrame': 'four months', 'description': 'Comparing the quality of the reconstructed cardiac cine images obtained with the cine-GRICS algorithm using:\n\n* the pneumatic belts alone\n* all MARMOT signals\n* signals from only one MARMOT sensor.\n\nThree 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'Motion', 'Respiratory movement', 'Artifacts correction'], 'conditions': ['Heart Disease']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nBreath-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.\n\nThe investigators intend to examine the efficacy of the MARMOT sensors for:\n\n* modelling and predicting the respiratory motions in abdominal scans,\n* correcting for the respiratory motion in a cardiac cine scan, via a reconstruction-based method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To not have cardiac, hepatic or renal pathology\n* To be more than 18\n* To be enrolled in a social security plan\n* To have signed an informed consent\n* To have preliminary medical examination\n\nExclusion Criteria:\n\n* Contraindication: implantable devices (pacemakers, defibrillators, cochlear implants, etc.), metallic foreign bodies\n* Impossibility to undergo MRI : claustrophobia, morbid obesity\n* Pregnancy or risk of pregnancy\n* Patient under a measure of legal protection'}, 'identificationModule': {'nctId': 'NCT02894632', 'acronym': 'MARMOT', 'briefTitle': 'MR Compatible Accelerometer for Respiratory MOTion Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'MR Compatible Accelerometer for Respiratory MOTion Measurement', 'orgStudyIdInfo': {'id': '2012-A00874-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Volunteers without cardiac, hepatic or renal pathology', 'interventionNames': ['Device: MRI compatible motion sensor (MARMOT)']}], 'interventions': [{'name': 'MRI compatible motion sensor (MARMOT)', 'type': 'DEVICE', 'description': "MRI with motion control (several motion sensors placed on the volunteer's body)", 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Nancy Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Laurent Bonnemains, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm - U947'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}