Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-28 @ 7:51 PM
Study NCT ID:
NCT00058058
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2003-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D018275', 'term': 'Carcinoma, Lobular'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Donna Hartfeil <dhartfeil@acr.org>', 'title': 'Senior Director of Protocol Management', 'organization': 'American College of Radiology Imaging Network'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 DAYS POST Intervention', 'eventGroups': [{'id': 'EG000', 'title': 'MRI Evaluation of Contralateral Breast', 'description': 'The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.\n\nMRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.', 'otherNumAtRisk': 1007, 'deathsNumAtRisk': 1007, 'otherNumAffected': 0, 'seriousNumAtRisk': 1007, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MRI Diagnostic Yield of Cancers in the Contralateral Breast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '936', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Standard Positive (RS+)', 'description': 'Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.'}, {'id': 'OG001', 'title': 'Reference Standard Negative (RS-)', 'description': 'Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.'}], 'classes': [{'title': 'Test + (Final BI-RAD 0, 4, 5)', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}]}]}, {'title': 'Test + (Initial MRI BI-RAD 4, 5/work-up)', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '831', 'groupId': 'OG001'}]}]}, {'title': 'Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx)', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '845', 'groupId': 'OG001'}]}]}, {'title': 'Test + (Initial MRI BI-RAD 0, 4, 5)', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}]}, {'title': 'Test + (Initial MRI BI-RAD 0, 3, 4, 5)', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}]}, {'title': 'Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)".', 'categories': [{'title': 'Test Positive (T+)', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}, {'title': 'Test Negative (T-)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '791', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation of diagnostic yield'}, {'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.032', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.043', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.032', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.043', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.\n\nthe "Test" status was defined based on combinations of the following 4 factors:\n\n1. The initial BI-RADs: from the MRI of the contralateral breast\n2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).\n3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI\n4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with an analyzable MRI'}, {'type': 'SECONDARY', 'title': 'MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '936', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Standard Positive (RS+)', 'description': 'Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.'}, {'id': 'OG001', 'title': 'Reference Standard Negative (RS-)', 'description': 'Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.'}], 'classes': [{'categories': [{'title': 'Test + (Final BI-RAD 0, 4, 5)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}, {'title': 'Test - (Final BI-RAD 1,2,3)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9091', 'ciLowerLimit': '0.7567', 'ciUpperLimit': '0.9809', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05004', 'groupDescription': 'Sensitivity estimate - estimates the P(T+\\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.8782', 'ciLowerLimit': '0.8555', 'ciUpperLimit': '0.8985', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0107', 'groupDescription': 'Specificity - estimates the P(T-\\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.2083', 'ciLowerLimit': '0.1452', 'ciUpperLimit': '0.2839', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0338', 'groupDescription': 'PPV estimate - estimates the P(D+\\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9964', 'ciLowerLimit': '0.9894', 'ciUpperLimit': '0.9993', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0021', 'groupDescription': 'B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0310', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.00556', 'groupDescription': 'B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the "Final BI-RADs", where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with an analyzable MRI'}, {'type': 'SECONDARY', 'title': 'AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '936', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Standard Positive (RS+)', 'description': 'Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.'}, {'id': 'OG001', 'title': 'Reference Standard Negative (RS-)', 'description': 'Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.'}], 'classes': [{'categories': [{'title': '1: Definitely not malignant', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}]}, {'title': '2: Probably not malignant', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}, {'title': '3: Possibly malignant', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': '4: Probably malignant', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': '5: Definitely malignant', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ROC analysis', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9355', 'ciLowerLimit': '0.8956', 'ciUpperLimit': '0.9753', 'estimateComment': 'exact CI', 'groupDescription': 'ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with an analyzable MRI'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MRI Evaluation of Contralateral Breast', 'description': 'The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.\n\nMRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1007'}]}, {'type': 'COMPLETED', 'comment': 'Completed MRI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '969'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Claustrophobic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'technical issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Poor positioning, illness,pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The data includes information on 1007 participants enrolled between April 1, 2003 and June 10, 2004 at 25 centers for data collected through August 8, 2006.', 'preAssignmentDetails': 'Patients were not imaged by MRI if they did not meet eligibility criteria, withdrew, or were otherwise unable to be scanned (claustrophobic, too large for scanner, illness, etc.)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MRI Evaluation of Contralateral Breast', 'description': 'The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.\n\nMRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '969', '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': '38', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '925', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '887', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2003-04-07', 'resultsFirstSubmitDate': '2017-12-24', 'studyFirstSubmitQcDate': '2003-04-08', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-29', 'studyFirstPostDateStruct': {'date': '2003-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI Diagnostic Yield of Cancers in the Contralateral Breast', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.\n\nthe "Test" status was defined based on combinations of the following 4 factors:\n\n1. The initial BI-RADs: from the MRI of the contralateral breast\n2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).\n3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI\n4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI'}], 'secondaryOutcomes': [{'measure': 'MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the "Final BI-RADs", where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4).'}, {'measure': 'AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast', 'timeFrame': 'within 90 days of a negative mammogram of the study breast', 'description': 'Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ', 'invasive ductal breast carcinoma', 'invasive lobular breast carcinoma', 'breast cancer in situ', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer', 'Magnetic resonance imaging', 'MRI'], 'conditions': ['Breast Cancer', 'Contralateral Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '22915431', 'type': 'RESULT', 'citation': 'DeMartini WB, Hanna L, Gatsonis C, Mahoney MC, Lehman CD. Evaluation of tissue sampling methods used for MRI-detected contralateral breast lesions in the American College of Radiology Imaging Network 6667 trial. AJR Am J Roentgenol. 2012 Sep;199(3):W386-91. doi: 10.2214/AJR.11.7000.'}, {'pmid': '20501712', 'type': 'RESULT', 'citation': 'Weinstein SP, Hanna LG, Gatsonis C, Schnall MD, Rosen MA, Lehman CD. Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667. Radiology. 2010 Jun;255(3):731-7. doi: 10.1148/radiol.10081712.'}, {'pmid': '17392300', 'type': 'RESULT', 'citation': 'Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.\n\nPURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.\n* Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.\n* Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).\n\nOUTLINE: This is a multicenter study.\n\nPatients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.\n\nPatients are followed at 12-18 and 24-30 months.\n\nPROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast\n\n * Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days\n* Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days\n* Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry\n* Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry\n* No remote history of breast cancer\n* No new breast symptoms within the past 60 days for which further evaluation is recommended\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No pacemaker\n* No magnetic aneurysm clips\n\nOther\n\n* Not pregnant\n* No implanted magnetic device\n* No severe claustrophobia\n* No other contraindications to MRI\n* No psychiatric, psychological, or other condition that would preclude informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 6 months since prior anticancer chemotherapy\n\nEndocrine therapy\n\n* No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00058058', 'acronym': 'ACRIN-6667', 'briefTitle': 'Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'American College of Radiology Imaging Network'}, 'officialTitle': 'MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000285698'}, 'secondaryIdInfos': [{'id': 'ACRIN-6667', 'type': 'OTHER', 'domain': 'American College of Radiology Imaging Network'}, {'id': 'U01CA079778', 'link': 'https://reporter.nih.gov/quickSearch/U01CA079778', 'type': 'NIH'}, {'id': 'U01CA080098', 'link': 'https://reporter.nih.gov/quickSearch/U01CA080098', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI Evaluation of Contralateral Breast', 'description': 'The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.', 'interventionNames': ['Procedure: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'otherNames': ['magnetic resonance imaging'], 'description': 'Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.', 'armGroupLabels': ['MRI Evaluation of Contralateral Breast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06102-5037', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20307', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Community Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62781', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21287-6681', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45267-0772', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Charles M. Barrett Cancer Center at University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center at University of Pennsylvania Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center at Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212-4772', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390-9085', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cancer Center at the University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5S 1A8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'D-53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitaetsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Constance Lehman, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seattle Cancer Care Alliance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American College of Radiology Imaging Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}