Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-05 @ 6:47 PM
Study NCT ID:
NCT03456427
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2018-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow
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': 'beth.heckel@med.ge.com', 'phone': '1-262-312-7269', 'title': 'Beth Heckel', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 Day', 'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'All subjects underwent standard of care imaging on one breast. The other breast was imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist properly positioned the breast and applied minimum compression. The subject was instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image was acquired. This was done for both standard views CC \\& MLO.\n\nTechnologist-Controlled (TC) Compression: TC compression was conducted per standard of care practices at the site.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Acceptable Overall Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants: Patient Assisted Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \\& MLO.'}, {'id': 'OG001', 'title': 'All Study Participants: Technologist Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nTechnologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'}], 'classes': [{'categories': [{'title': 'Image Quality: Acceptable', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Image Quality: Unacceptable', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Repeat Image Acquisitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants: Patient Assisted Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \\& MLO.'}, {'id': 'OG001', 'title': 'All Study Participants: Technologist Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nTechnologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'}], 'classes': [{'title': 'Technologist-Indicated Repeat Acquisitions', 'categories': [{'title': 'Repeat Acquisitions Indicated', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Repeat Acquisition not Indicated', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Reader-Indicated Repeat Acquisitions', 'categories': [{'title': 'Repeat Acquisitions Indicated', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Repeat Acquisition not Indicated', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Acceptable Mammographic Attributes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants: Patient Assisted Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \\& MLO.'}, {'id': 'OG001', 'title': 'All Study Participants: Technologist Compression', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nTechnologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'}], 'classes': [{'title': 'Breast Positioning', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Exposure and Visualization', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Breast Compression', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sharpness due to Motion', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Image Contrast', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tissue Visibility at skin line', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Noise', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Artifacts due to image processing or other factors', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All subjects underwent standard of care imaging on one breast. The other breast was imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist properly positioned the breast and applied minimum compression. The subject was instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image was acquired. This was done for both standard views CC \\& MLO.\n\nTechnologist-Controlled (TC) Compression: TC compression was conducted per standard of care practices at the site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.\n\nPatient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \\& MLO.\n\nTechnologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.45', 'spread': '10.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menopausal Status', 'classes': [{'categories': [{'title': 'Post-Menopausal', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Perimenopause', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Pre-Menopausal', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-09', 'size': 834027, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-04T12:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2018-02-23', 'resultsFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-09', 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Acceptable Overall Image Quality', 'timeFrame': '1 Day', 'description': 'The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.'}], 'secondaryOutcomes': [{'measure': 'Number of Repeat Image Acquisitions', 'timeFrame': '1 Day', 'description': 'To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.'}, {'measure': 'Percentage of Acceptable Mammographic Attributes', 'timeFrame': '1 Day', 'description': 'To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.", 'detailedDescription': 'The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the "breast of interest," which will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral oblique) PA compression and image acquisition, followed by two-view technologist-controlled (TC) compression and image acquisition. The breast of interest will be randomly assigned to either the first breast imaged during the exam or the second breast imaged. TC compression and imaging, and procedures performed on the subject\'s other breast will be conducted per standard of care.\n\nFollowing image acquisition, 3D image quality evaluation will be conducted by Mammography Quality Standards Act-qualified readers. Prior to the reading session, images will be de-identified and the following information will be removed from the DICOM header to blind readers to the compression mode used during acquisition: time stamp, compression force, and breast thickness. The image sets will also be randomized for presentation during the image attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set collected from each subject\'s breast of interest and assess the acceptability of image attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide adjudication, if there is disagreement for a given image set\'s overall clinical image quality.\n\nWorkflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected.\n\nThe proportion of PAC image sets that are of equal or higher acceptability than TC image sets will be calculated. A 95% confidence interval will be calculated using asymptotic method with continuity correction. The proportion of image sets indicated for repeated image acquisition when using PA mode or TC mode will be summarized. Other endpoint data will be summarized using descriptive statistics. No statistical hypothesis is being tested in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are women aged 40 years or older;\n2. Are asymptomatic and scheduled for screening mammography;\n3. Have left and right breasts;\n4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;\n5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;\n6. Are able and willing to comply with study procedures; and\n7. Are able and willing to provide written informed consent to participate.\n\nExclusion Criteria:\n\n1. Are women aged 40 years or older;\n2. Are asymptomatic and scheduled for screening mammography;\n3. Have left and right breasts;\n4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;\n5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;\n6. Are able and willing to comply with study procedures; and\n7. Are able and willing to provide written informed consent to participate."}, 'identificationModule': {'nctId': 'NCT03456427', 'acronym': '3D PAC', 'briefTitle': 'Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow', 'orgStudyIdInfo': {'id': '124.03-2017-GES-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Study Participants', 'description': 'All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', 'interventionNames': ['Device: Patient-Assisted Compression (PAC)', 'Device: Technologist-Controlled (TC) Compression']}], 'interventions': [{'name': 'Patient-Assisted Compression (PAC)', 'type': 'DEVICE', 'description': 'The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) \\& Mediolateral Oblique (MLO).', 'armGroupLabels': ['All Study Participants']}, {'name': 'Technologist-Controlled (TC) Compression', 'type': 'DEVICE', 'description': 'TC compression will be conducted per standard of care practices at the site.', 'armGroupLabels': ['All Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}