Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-02 @ 10:45 AM
Study NCT ID:
NCT03243435
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sienna+MR Long-term Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'I) Analysis if the supraparamegnetic Tracer is still detectable', 'timeFrame': '04/2017', 'description': 'Analysis by two expert radiologists'}], 'secondaryOutcomes': [{'measure': 'Analysis to which degree of impairment of Imaging is detected', 'timeFrame': '04/2017', 'description': 'Description as "no impairment", impairment, but Interpretation of Images possible", "impairment, Image Interpretation impossible"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all 34 patients from the previous study are included', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion:\n\n* participation in previous study\n* informed consent\n* no contraindications for MRI scan\n\nexclusion:\n\n* contraindications for MRI scan'}, 'identificationModule': {'nctId': 'NCT03243435', 'briefTitle': 'Sienna+MR Long-term Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baden'}, 'officialTitle': 'Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers', 'orgStudyIdInfo': {'id': '2016-00808'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Native 1,5 Tesla breast MRI group', 'description': 'From all patients a 1,5 Tesla MRI of the breast will be obtained', 'interventionNames': ['Procedure: Native 1,5 Tesla breast MRI']}], 'interventions': [{'name': 'Native 1,5 Tesla breast MRI', 'type': 'PROCEDURE', 'armGroupLabels': ['Native 1,5 Tesla breast MRI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Breast Center', 'investigatorFullName': 'Cornelia Leo', 'investigatorAffiliation': 'Kantonsspital Baden'}}}}