Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-07 @ 11:46 AM
Study NCT ID:
NCT01806558
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2013-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.', 'timeFrame': '1 year', 'description': 'Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'molecular breast imaging', 'breast', 'breast lesion'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21045179', 'type': 'RESULT', 'citation': "Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2."}], 'seeAlsoLinks': [{'url': 'http://www.youtube.com/watch?v=DOQBLe8MdH0', 'label': 'Mayo Clinic You Tube Channel'}]}, 'descriptionModule': {'briefSummary': 'A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:\n\n 1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \\>0.5 cm and \\< 2 cm in size and has had or will have additional workup with focused ultrasound.\n 2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \\> 0.5 cm and \\< 2 cm in size.\n 3. Have a positive finding on MBI that is \\< 2 cm in size and requires additional diagnostic workup with focused ultrasound.\n\nExclusion Criteria:\n\n1. Are unable to understand and sign the consent form\n2. Are pregnant or lactating\n3. Are physically unable to sit upright and still for 40 minutes\n4. Have undergone bilateral mastectomy\n5. Are not scheduled to undergo conventional ultrasound'}, 'identificationModule': {'nctId': 'NCT01806558', 'acronym': 'MBI/US', 'briefTitle': 'Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions', 'orgStudyIdInfo': {'id': '12-004900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with lesion on MBI', 'description': 'Women with lesion on MBI', 'interventionNames': ['Procedure: Molecular Breast Imaging']}], 'interventions': [{'name': 'Molecular Breast Imaging', 'type': 'PROCEDURE', 'otherNames': ['MBI'], 'description': 'Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.', 'armGroupLabels': ['Women with lesion on MBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': "Michael K O'Connor, PhD, R-D", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}