Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT01569802
Status:
UNKNOWN
Last Update Posted:
2012-04-03
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
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': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-30', 'studyFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall Rate', 'timeFrame': 'up to 1 year', 'description': 'measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population'}], 'secondaryOutcomes': [{'measure': 'Cancer detection Rate', 'timeFrame': 'up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer screening', 'tomosynthesis', 'FFDM'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'radiology clinic screening population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is female of any race and ethnicity\n* The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.\n\nExclusion Criteria:\n\n* Patient chooses standard 2D mammography over a combination 2D + 3D mammogram'}, 'identificationModule': {'nctId': 'NCT01569802', 'briefTitle': 'A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population', 'organization': {'class': 'OTHER', 'fullName': 'Rose Imaging Specialists, P.A.'}, 'officialTitle': 'A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population', 'orgStudyIdInfo': {'id': '11-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'screening'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andra Tidwell, RT(R)(M)', 'role': 'CONTACT', 'email': 'atidwell@uspi.com', 'phone': '281-580-6171'}], 'facility': 'TOPS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rose Imaging Specialists, P.A.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}