Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01698658
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2012-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
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': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution', 'timeFrame': 'At time of procedure', 'description': "For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method."}], 'secondaryOutcomes': [{'measure': 'Ability of the system to identify pathological features previously identified by other imaging modalities', 'timeFrame': 'At time of procedure', 'description': 'The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.'}, {'measure': 'Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)', 'timeFrame': 'At time of procedure', 'description': 'Will be calculated along with 95% confidence intervals.'}, {'measure': 'Sound speed as a percentage measure of dense breast tissue', 'timeFrame': 'At time of procedure', 'description': 'Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.\n\nII. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.\n\nIII. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.\n\nIV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.\n\nOUTLINE:\n\nPatients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for mammogram, breast ultrasound and/or breast MRI\n* Breast size less than 22 cm diameter (ring diameter is 22cm)\n* Able to read or understand and provide informed consent\n* Weight \\< 350lbs (patient bed max weight)\n* Non-pregnant and non-lactating\n* No open breast or chest wounds\n* No active skin infection\n* No serious medical or psychiatric illnesses that would prevent informed consent'}, 'identificationModule': {'nctId': 'NCT01698658', 'briefTitle': 'Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner', 'orgStudyIdInfo': {'id': '2011-201'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01745', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA022453', 'link': 'https://reporter.nih.gov/quickSearch/P30CA022453', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (SoftVue ultrasound tomography)', 'description': 'Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.', 'interventionNames': ['Other: ultrasound tomography', 'Procedure: magnetic resonance imaging']}], 'interventions': [{'name': 'ultrasound tomography', 'type': 'OTHER', 'description': 'Undergo ultrasound tomography using SoftVue', 'armGroupLabels': ['Diagnostic (SoftVue ultrasound tomography)']}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'otherNames': ['MRI', 'NMR imaging', 'NMRI', 'nuclear magnetic resonance imaging'], 'description': 'Undergo MRI of the breast', 'armGroupLabels': ['Diagnostic (SoftVue ultrasound tomography)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Alit Amit-Yousif, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alit Amit-Yousif', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}}