Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT03482557
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-17', '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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmccall1@bidmc.harvard.edu', 'phone': '617-418-9216', 'title': 'Marc Mccall', 'organization': 'Beth Israel Deaconess MEdical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Data were collected at the time of any research imaging exams that were acquired and within 1 year of the exam.', 'eventGroups': [{'id': 'EG000', 'title': 'Screening CESM Before Biopsy', 'description': "Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care.\n\nMRI: Breast MRI will be performed, if not already performed as part of clinical care.\n\nCESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care.\n\nBiopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also.\n\nReader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.\n\nCESM: Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone\n\nMRI: MRI uses magnets to create a detailed image of the tissues and bones inside of the body", 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Screening MRI Before Biopsy', 'description': "Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care.\n\nMRI: Breast MRI will be performed, if not already performed as part of clinical care.\n\nCESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care.\n\nBiopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also.\n\nReader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.\n\nCESM: Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone\n\nMRI: MRI uses magnets to create a detailed image of the tissues and bones inside of the body", 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancers Identified With CESM', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI'}, {'id': 'OG001', 'title': 'Cancers Identified With Screening MRI', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '.885', 'upperLimit': '0.926'}, {'value': '.91', 'groupId': 'OG001', 'lowerLimit': '0.894', 'upperLimit': '0.925'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.', 'unitOfMeasure': 'Probability of malignancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CESM', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs abbreviated MRI'}, {'id': 'OG001', 'title': 'Screening Abbreviated MRI', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs abbreviated MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '.906', 'groupId': 'OG000', 'lowerLimit': '.885', 'upperLimit': '0.926'}, {'value': '.894', 'groupId': 'OG001', 'lowerLimit': '.859', 'upperLimit': '.929'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.', 'unitOfMeasure': 'Probability of malignancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CESM', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs 2D MAmmography'}, {'id': 'OG001', 'title': 'Screening 2D Mammography', 'description': 'Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs 2D Mammography'}], 'classes': [{'categories': [{'measurements': [{'value': '.906', 'groupId': 'OG000', 'lowerLimit': '.885', 'upperLimit': '.926'}, {'value': '.788', 'groupId': 'OG001', 'lowerLimit': '.756', 'upperLimit': '.820'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.', 'unitOfMeasure': 'Probability of malignancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening CESM and MRI', 'description': 'Each enrolled participant will receive both a CESM and MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CEM and MRI must be performed prior to biopsy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '132', 'preAssignmentDetails': '132 patients were included in the reader study. 42 patients had imaging acquired as part of clinical trial NCT02275871, 78 as part of clinical trial NCT03482557, and 12 as part of clinical care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Screening CESM and Breast MRI', 'description': 'Each enrolled participant will receive both a CESM and MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CEM and MRI must be performed prior to biopsy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '116', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-24', 'size': 9891436, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-21T15:31', 'hasProtocol': True}, {'date': '2023-11-22', 'size': 3609486, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-13T09:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2018-03-23', 'resultsFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-07', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening', 'timeFrame': '2 years', 'description': 'We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening', 'timeFrame': '2 years', 'description': 'Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.'}, {'measure': 'Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening', 'timeFrame': '2 years', 'description': 'We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'screening', 'breast MRI', 'contrast enhanced spectral mammography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening', 'detailedDescription': 'Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.\n\nContrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.\n\nFor this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CESM and MRI exam performed within 3 months of one another.\n* CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)\n* CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).\n* MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted\n\nExclusion Criteria:\n\n* Imaging sets with implants.\n* Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.\n* Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available'}, 'identificationModule': {'nctId': 'NCT03482557', 'briefTitle': 'Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening', 'orgStudyIdInfo': {'id': '17-689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contrast-Enhanced Spectral Mammography', 'description': 'Each enrolled participant will receive a CESM either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CESM must be performed prior to biopsy.', 'interventionNames': ['Device: CESM']}, {'type': 'EXPERIMENTAL', 'label': 'Breast MRI', 'description': 'Each enrolled participant will receive an MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the MRI must be performed prior to biopsy.', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'CESM', 'type': 'DEVICE', 'otherNames': ['Contrast Enhanced Spectral Mammography'], 'description': 'Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone', 'armGroupLabels': ['Contrast-Enhanced Spectral Mammography']}, {'name': 'MRI', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging'], 'description': 'MRI uses magnets to create a detailed image of the tissues and bones inside of the body', 'armGroupLabels': ['Breast MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Olga Brook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-Chair of Research', 'investigatorFullName': 'Olga Brook', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}