Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-06 @ 8:46 AM
Study NCT ID:
NCT00859261
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2009-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D047688', 'term': 'Breast Cyst'}], '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'}, {'id': 'D003560', 'term': 'Cysts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.', 'timeFrame': '1 year', 'description': 'Assess the quality of 3 D ultrasound in comparison to conventional mammography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Tumor', 'Breast Cysts']}, 'descriptionModule': {'briefSummary': 'The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.', 'detailedDescription': 'To assist in the developement of 3 dimensional breast ultrasound imaging and when possible compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can provide important information not found on mammograms or routine breast ultrasound.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women OR\n* Women with suspected benign masses who may/or may not be going to biopsy\n* Women with cysts where no biopsy is recommended\n\nExclusion Criteria:\n\n* Women who are pregnant\n* Women with breast implants\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT00859261', 'briefTitle': 'Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': '2D Silicon Transducer-Compression Plates for Breast Ultrasound', 'orgStudyIdInfo': {'id': 'HUM 15464'}, 'secondaryIdInfos': [{'id': '2R01CA091713', 'link': 'https://reporter.nih.gov/quickSearch/2R01CA091713', 'type': 'NIH'}, {'id': 'R01CA115267', 'link': 'https://reporter.nih.gov/quickSearch/R01CA115267', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast imaging using Ultrasound and Photoacoustic', 'description': 'Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.', 'interventionNames': ['Procedure: Experimental 3D Breast Ultrasound imaging', 'Procedure: Experimental Photoacoustic Imaging']}], 'interventions': [{'name': 'Experimental 3D Breast Ultrasound imaging', 'type': 'PROCEDURE', 'description': 'Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete.', 'armGroupLabels': ['Breast imaging using Ultrasound and Photoacoustic']}, {'name': 'Experimental Photoacoustic Imaging', 'type': 'PROCEDURE', 'otherNames': ['Photoacoustic Tomography (PAT)'], 'description': 'Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete.', 'armGroupLabels': ['Breast imaging using Ultrasound and Photoacoustic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Paul Carson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Basic Science Division'}]}, '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 ( Ph.D )', 'investigatorFullName': 'Paul L. Carson Ph.D', 'investigatorAffiliation': 'University of Michigan'}}}}