Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-09 @ 12:14 PM
Study NCT ID:
NCT01852032
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmbrock@ucdavis.edu', 'phone': '916-734-3101', 'title': 'John Brock Staff Research Associate', 'organization': 'UC Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Beta of CT Coronal View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '0.424', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'unitOfMeasure': 'power-law slope(B)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with suspected breast cancer'}, {'type': 'PRIMARY', 'title': 'Beta of CT Sagittal View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '0.352', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'unitOfMeasure': 'power-law slope(B)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with suspected breast cancer'}, {'type': 'PRIMARY', 'title': 'Beta of CT Axial View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '0.397', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'unitOfMeasure': 'power-law slope(B)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with suspected breast cancer'}, {'type': 'PRIMARY', 'title': 'Beta of Tomosynthesis Craniocaudal View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '0.361', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'unitOfMeasure': 'power-law slope(B)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with suspected breast cancer'}, {'type': 'PRIMARY', 'title': 'Beta of Tomosynthesis Medial Lateral Oblique View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.10', 'spread': '0.315', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'unitOfMeasure': 'power-law slope(B)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with suspected breast cancer'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Breast Cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'greater than 35 years old', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Female participants over the age of 35 with suspected breast cancer'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2012-10-29', 'resultsFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-13', 'studyFirstPostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beta of CT Coronal View', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}, {'measure': 'Beta of CT Sagittal View', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}, {'measure': 'Beta of CT Axial View', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}, {'measure': 'Beta of Tomosynthesis Craniocaudal View', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}, {'measure': 'Beta of Tomosynthesis Medial Lateral Oblique View', 'timeFrame': 'Day 1', 'description': 'frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\\^-B.\n\nbeta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.', 'detailedDescription': 'The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 35 years of age or older\n* While male patients will not be explicitly excluded, it is expected that all patients in this study will be women\n* Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5\n* Scheduled for ultrasound or stereotactic core biopsy\n* Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.\n* Ability to understand risks, procedures, and benefits involved\n\nExclusion Criteria:\n\n* Recent breast biopsy\n* History of breast augmentation implant\n* Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding\n* History of moderate or severe adverse reaction to iodinated contrast injection\n* Recent serum creatinine ≥ 1.5 mg/dL\n* History of Diabetes Mellitus\n* Currently taking Glucophage or Glucovance (Metformin)\n* History of chronic asthma\n* History of allergy to iodine\n* Multiple food and/or drug allergy\n* Renal disease\n* History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold'}, 'identificationModule': {'nctId': 'NCT01852032', 'briefTitle': 'Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis', 'orgStudyIdInfo': {'id': '221183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast cancer Patients', 'description': 'Tomosynthesis Breast Scanning is done and breast CT Scanning is done.', 'interventionNames': ['Radiation: Tomosynthesis Breast Scanning', 'Radiation: Breast CT Scanning']}], 'interventions': [{'name': 'Tomosynthesis Breast Scanning', 'type': 'RADIATION', 'description': 'The breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography', 'armGroupLabels': ['Breast cancer Patients']}, {'name': 'Breast CT Scanning', 'type': 'RADIATION', 'description': 'CT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene "hammock," which will allow the subject\'s entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan.', 'armGroupLabels': ['Breast cancer Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'John M Boone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}