Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 2:37 PM
Study NCT ID:
NCT04030104
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2019-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optoacoustic Images Versus Imagio® Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}}}, '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': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschaeffer@senomedical.com', 'phone': '210-615-6501', 'title': 'Vice President of Clinical Operations', 'organization': 'Seno Medical Instruments, Inc.'}, 'certainAgreement': {'otherDetails': 'The results of the study are the property of Seno Medical Instruments, Inc. All publications (manuscripts, abstracts or other modes of presentation) must be submitted and reviewed and approved in writing by Seno Medical Instruments, Inc., in advance of submission. The over all study results will first be submitted as a primary paper.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Overall (Subjects Randomly Selected From PIONEER-01 Study)', 'description': 'Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 14, 'seriousNumAtRisk': 480, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Paraesthesia', 'notes': 'Tingling sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Post-procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin warm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Device breakage', 'notes': 'Right saline breast implant rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung cancer', 'notes': 'Non-small cell lung cancer Stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gain in Specificity at Fixed 98% Sensitivity (fSp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'IUS alone imaging'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '38.22', 'groupId': 'OG000', 'lowerLimit': '24.85', 'upperLimit': '51.59'}, {'value': '47.20', 'groupId': 'OG001', 'lowerLimit': '35.91', 'upperLimit': '58.49'}]}]}], 'analyses': [{'pValue': '0.0268', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for statistical significance \\<0.05', 'statisticalMethod': 'Random Reader, Random Mass', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Curve Fitting Method: Empirical'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.', 'unitOfMeasure': '% benign+TPB masses correctly identified', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-diagnose (ITD)'}, {'type': 'SECONDARY', 'title': 'Negative Likelihood Ratio (NLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio Alone', 'description': 'IUS alone imaging'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '0.053', 'groupId': 'OG000', 'lowerLimit': '0.037', 'upperLimit': '0.070'}, {'value': '0.047', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '0.062'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'NLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). NLR = \\[(1-sensitivity) / specificity\\].', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-diagnose (ITD)'}, {'type': 'SECONDARY', 'title': 'Positive Likelihood Ratio (PLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'IUS alone imaging'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '1.548', 'groupId': 'OG000', 'lowerLimit': '1.498', 'upperLimit': '1.597'}, {'value': '1.959', 'groupId': 'OG001', 'lowerLimit': '1.870', 'upperLimit': '2.051'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'PLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). PLR = \\[sensitivity / (1-specificity)\\].', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Total population of subjects/masses'}, {'type': 'SECONDARY', 'title': 'Partial Area Under the Curve (pAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'IUS Alone Imaging'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0205', 'groupId': 'OG000', 'lowerLimit': '0.0191', 'upperLimit': '0.0219'}, {'value': '0.0244', 'groupId': 'OG001', 'lowerLimit': '0.0230', 'upperLimit': '0.0258'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'pAUC considers only the region of the area under the ROC curve that corresponds to clinically relevant values of sensitivity, defined as 95% to 100%, for Imagio IUS+OA vs. IUS alone, averaged across 15 readers. Both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). A higher pAUC indicates better diagnostic accuracy.', 'unitOfMeasure': 'Percentage of Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-diagnose (ITD)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall (Subjects Randomly Selected From PIONEER-01 Study)', 'description': 'Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'New Independent Reader Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study- (NCT01943916)). Reader-02 study execution dates: 30 Jul 2019 to 3 Nov 2019', 'preAssignmentDetails': 'Imagio Ultrasound (IUS) and Imagio optoacoustic/ultrasound (IUS+OA) images of breast masses previously acquired from the PIONEER-01 study (NCT01943916) referenced above were used for this study. Reader-02 was a single-arm sequentially read multi reader/case (MRMC) study comparing IUS vs Imagio (IUS+OA). New readers were recruited-NO new subjects/masses. Results were based on biopsy diagnosis or truth panel decision as ground truth obtained during PIONEER-01.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall (Subjects Randomly Selected From PIONEER-01 Study)', 'description': 'Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data derived from PIONEER-01 for sub set of 480 cases read during Reader-02 Study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '14.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '480', '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': '87', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '387', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '389', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mass Diagnosis', 'classes': [{'categories': [{'title': 'Subjects (Benign+TPB+HR)', 'measurements': [{'value': '300', 'groupId': 'BG000'}]}, {'title': 'Subjects (Cancer)', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mass diagnosis by biopsy result or Truth Panel decision', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-diagnose (ITD)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-04', 'size': 1317085, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-02T14:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Readers will not be provided with information regarding the initial patient diagnosis'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2020-04-02', 'completionDateStruct': {'date': '2019-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2019-05-22', 'dispFirstSubmitQcDate': '2021-04-09', 'resultsFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2019-07-18', 'dispFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-09', 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gain in Specificity at Fixed 98% Sensitivity (fSp)', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.'}], 'secondaryOutcomes': [{'measure': 'Negative Likelihood Ratio (NLR)', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'NLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). NLR = \\[(1-sensitivity) / specificity\\].'}, {'measure': 'Positive Likelihood Ratio (PLR)', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'PLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). PLR = \\[sensitivity / (1-specificity)\\].'}, {'measure': 'Partial Area Under the Curve (pAUC)', 'timeFrame': 'Baseline to 12 months +/- 30 days follow-up', 'description': 'pAUC considers only the region of the area under the ROC curve that corresponds to clinically relevant values of sensitivity, defined as 95% to 100%, for Imagio IUS+OA vs. IUS alone, averaged across 15 readers. Both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). A higher pAUC indicates better diagnostic accuracy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.', 'detailedDescription': 'This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study.\n\nImagio® \\[Ultrasound (IUS) + Optoacoustic (OA)\\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Images from female patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)\n* Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol\n* Patient age, indication for study entry and available medical history\n* Evaluable mammograms and OA and IUS video loops and stills for each mass\n\nExclusion Criteria:\n\n* Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers\n* Reader-02 Proficiency Test and training cases'}, 'identificationModule': {'nctId': 'NCT04030104', 'acronym': 'Reader-02', 'briefTitle': 'Optoacoustic Images Versus Imagio® Ultrasound', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seno Medical Instruments Inc.'}, 'officialTitle': 'Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy', 'orgStudyIdInfo': {'id': 'Reader-02 Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Imagio IUS', 'description': 'Read 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked.', 'interventionNames': ['Device: Reader Study - Imagio Ultrasound', 'Device: Mammography']}, {'type': 'EXPERIMENTAL', 'label': 'Imagio (IUS+OA)', 'description': 'Read 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked.', 'interventionNames': ['Device: Reader Study Imagio Ultrasound + Optoacoustic Imaging', 'Device: Mammography']}], 'interventions': [{'name': 'Reader Study - Imagio Ultrasound', 'type': 'DEVICE', 'description': 'Imagio ultrasound images to be reviewed as part of Reader study', 'armGroupLabels': ['Imagio IUS']}, {'name': 'Reader Study Imagio Ultrasound + Optoacoustic Imaging', 'type': 'DEVICE', 'description': 'Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study', 'armGroupLabels': ['Imagio (IUS+OA)']}, {'name': 'Mammography', 'type': 'DEVICE', 'otherNames': ['Mammo'], 'description': 'Mammography as available per standard of care', 'armGroupLabels': ['Imagio (IUS+OA)', 'Imagio IUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'American College of Radiology Center for Research and Innovation', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Shaan Schaeffer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seno Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seno Medical Instruments Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}