Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT01928992
Status:
COMPLETED
Last Update Posted:
2016-11-21
First Post:
2013-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2013-08-22', 'lastUpdatePostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per Breast AUC', 'timeFrame': '1 Day', 'description': 'Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.'}], 'secondaryOutcomes': [{'measure': 'Subject Recall Rate', 'timeFrame': '1 Day', 'description': 'For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mammography', '3D', 'Breast Cancer Detection'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with screening and diagnostic 3D or 2D mammography', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects participating in prior FMSU protocol with known clinical status\n\nExclusion Criteria:\n\n* Subjects with unkown clinical status\n* Subjects not truthed in prior FMSU study'}, 'identificationModule': {'nctId': 'NCT01928992', 'acronym': '3DM', 'briefTitle': 'Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujifilm Medical Systems USA, Inc.'}, 'officialTitle': 'A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study', 'orgStudyIdInfo': {'id': 'FMSU2011-003B'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D', 'description': 'Subjects that undergo 3D mammography', 'interventionNames': ['Device: 3D']}, {'label': '2D', 'description': 'Subjects that undergo 2D mammography', 'interventionNames': ['Device: 2D']}], 'interventions': [{'name': '3D', 'type': 'DEVICE', 'description': 'subjects that underwent 3D mammography', 'armGroupLabels': ['3D']}, {'name': '2D', 'type': 'DEVICE', 'description': 'those subjects that underwent 2D mammography', 'armGroupLabels': ['2D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'ACR / Image Metrix', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': "Carl D'Orsi, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujifilm Medical Systems USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}