Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-29 @ 10:48 AM
Study NCT ID:
NCT05218460
Status:
RECRUITING
Last Update Posted:
2022-09-07
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2027-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality based on standard imaging quality criteria', 'timeFrame': '6 months after the last inclusion', 'description': 'The image quality will be appreciated visually at least by a radiologist or a researcher.'}, {'measure': 'Signal quality based on standard signal quality criteria', 'timeFrame': '6 months after the last inclusion', 'description': 'The signal quality will be appreciated visually at least by a radiologist or a researcher.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation.', 'timeFrame': '6 months after the last inclusion', 'description': 'ignal to Noise Ratio will be measured in arbitrary units.'}, {'measure': 'Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation.', 'timeFrame': '6 months after the last inclusion', 'description': 'Contrast to Noise Ratio will be measured in arbitrary units.'}, {'measure': 'Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation.', 'timeFrame': '6 months after the last inclusion', 'description': 'Absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale (1 to 5 ; 1 is the worst score and 5 is the better score).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Pathology']}, 'descriptionModule': {'briefSummary': 'The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for all subjects :\n\n* to be over 18 year-old,\n* to be enrolled in a social security plan,\n* to have underwent a pre-inclusion medical examination,\n* to give a written consent.\n\nInclusion Criteria for volunteers with pathology :\n\n\\- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).\n\nExclusion Criteria for all subjects :\n\n* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ),\n* subject under a measure of legal protection,\n* Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.'}, 'identificationModule': {'nctId': 'NCT05218460', 'acronym': 'EDEN', 'briefTitle': 'Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects', 'orgStudyIdInfo': {'id': '2021-A00243-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects will have an MRI examination', 'interventionNames': ['Device: MRI examination']}], 'interventions': [{'name': 'MRI examination', 'type': 'DEVICE', 'description': 'All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.', 'armGroupLabels': ['All subjects will have an MRI examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien MANDRY, MD, PhD', 'role': 'CONTACT', 'email': 'd.mandry@chru-nancy.fr', 'phone': '+33383154202'}], 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Damien MANDRY, MD, PhD', 'role': 'CONTACT', 'email': 'd.mandry@chru-nancy.fr', 'phone': '+33383154202'}, {'name': 'Gabriela HOSSU, PhD', 'role': 'CONTACT', 'email': 'g.hossu@chru-nancy.fr', 'phone': '+33383155096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Damien MANDRY', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}