Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT00721435
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2008-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
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': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-22', 'studyFirstSubmitDate': '2008-07-22', 'studyFirstSubmitQcDate': '2008-07-22', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.', 'timeFrame': 'To be determined later.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Mass Cystic', 'Benign Mass']}, 'descriptionModule': {'briefSummary': 'The study will evaluate and refine a breast screening and diagnosis device.', 'detailedDescription': 'The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To participate in this research study you must be a female over the age of 25\n* Have had a normal mammogram or are scheduled for a breast biopsy\n* Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.\n\nExclusion Criteria:\n\n* Male\n* Under the age of 25\n* Documented breast cancer'}, 'identificationModule': {'nctId': 'NCT00721435', 'briefTitle': 'Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions', 'orgStudyIdInfo': {'id': 'HUM00045519 (2002-0584)'}, 'secondaryIdInfos': [{'id': 'R01CA091713', 'link': 'https://reporter.nih.gov/quickSearch/R01CA091713', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D Tomosynthesis & 3D Ultrasound for breast masses', 'description': 'Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.', 'interventionNames': ['Procedure: 3D Tomosynthesis and ultrasound imaging']}, {'type': 'EXPERIMENTAL', 'label': '3D Tomosynthesis/ 3D Ultrasound for healthy subjects', 'description': 'Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.', 'interventionNames': ['Procedure: 3D Tomosynthesis and ultrasound imaging']}], 'interventions': [{'name': '3D Tomosynthesis and ultrasound imaging', 'type': 'PROCEDURE', 'description': '3D tomosynthesis \\& ultrasound imaging for scanning masses or healthy breast tissue', 'armGroupLabels': ['3D Tomosynthesis & 3D Ultrasound for breast masses', '3D Tomosynthesis/ 3D Ultrasound for healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109-0554', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Paul L Carson, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paul L. Carson Ph.D', 'investigatorAffiliation': 'University of Michigan'}}}}