Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-29 @ 10:27 PM
Study NCT ID:
NCT00722059
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2008-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and 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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of digital tomosynthesis and digital mammography test performance.', 'timeFrame': '3 weeks', 'description': 'Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms', 'Breast Abnormalities']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females 30 years of age or older.\n* Dense Breasts.\n* Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.\n* Suspicious or palpable mass and scheduled for biopsy.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Prior personal history of breast cancer.\n* Prior breast augmentation with implants or silicon injection. male patients.\n* No two view mammogram as part of breast imaging evaluation.\n* Breast density of almost entirely fatty/scattered fibroglandular densities.'}, 'identificationModule': {'nctId': 'NCT00722059', 'briefTitle': 'Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts', 'orgStudyIdInfo': {'id': 'HUM 13236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.', 'interventionNames': ['Procedure: Breast Tomosynthesis']}], 'interventions': [{'name': 'Breast Tomosynthesis', 'type': 'PROCEDURE', 'description': '3D breast imaging', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Alexis V. Nees, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexis V. Nees M.D.', 'investigatorAffiliation': 'University of Michigan'}}}}