Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02826369
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Compressed Sensing in Breast MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between compressed sensing and standard image acquisition', 'timeFrame': '1 day', 'description': 'Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions'}], 'secondaryOutcomes': [{'measure': 'Analysis of dammage contours', 'timeFrame': '1 day', 'description': 'Analysis of lesions contours will be performed according to Bi-RADS classification'}, {'measure': 'Image quality in compressed sensing acquisition', 'timeFrame': '1 day', 'description': 'The image quality will be evaluated using a quality scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Algorithms', 'Image Processing, Computer-Assisted/methods*', 'Magnetic Resonance Imaging/methods*', 'Data Compression', 'Breast Neoplasms'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.\n\nThese curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.\n\nIt seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient to benefit a MRI in the assessment for a breast carcinoma\n* Age \\>18 years old\n* Assessment on 3.0 Tesla in Magnetic Resonance Imaging\n* ECOG performance status ≤ 3\n* Ability to provide an informed written consent form\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Claustrophobia\n* Contraindication to the injection of gadolinium contrast medium\n* Contraindication to MRI\n* Persons deprived of liberty or under supervision'}, 'identificationModule': {'nctId': 'NCT02826369', 'acronym': 'COMPRIM', 'briefTitle': 'Use of Compressed Sensing in Breast MRI', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Use of Compressed Sensing in Breast MRI', 'orgStudyIdInfo': {'id': '2015-A00581-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3.0 Tesla in Magnetic Resonance Imaging', 'interventionNames': ['Other: 3.0 Tesla in Magnetic Resonance Imaging']}], 'interventions': [{'name': '3.0 Tesla in Magnetic Resonance Imaging', 'type': 'OTHER', 'description': 'Eligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition.\n\nThe images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition.', 'armGroupLabels': ['3.0 Tesla in Magnetic Resonance Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'OLDRINI Guillaume, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}