Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT01766102
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-operative Digital vs. Standard Mammography
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': 'MSPECHT@mgh.harvard.edu', 'phone': '617-726-0340', 'title': 'Michelle Specht, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse Event information was not collected as a part of this trial', 'eventGroups': [{'id': 'EG000', 'title': 'Intra-operative Mammography', 'description': "Intra-operative Specimen Mammography\n\nIntra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Mammography', 'description': 'Standard Specimen Mammography\n\nStandard Mammography: There is not an added device associated with this arm.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Operative Time Savings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intra-operative Mammography', 'description': "Intra-operative Specimen Mammography\n\nIntra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"}, {'id': 'OG001', 'title': 'Standard Mammography', 'description': 'Standard Specimen Mammography\n\nStandard Mammography: There is not an added device associated with this arm.'}], 'classes': [{'title': 'Procedure Time', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '138'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '140'}]}]}, {'title': 'OR Time', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '180'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '177'}]}]}], 'analyses': [{'pValue': '0.716', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'H0: Procedure time is not significantly different based on mammography type used', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.676', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'H0: Operating room time is not significantly different based on mammography type used', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the procedure (approximately 1 week after randomization)', 'description': 'To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Radiographic and Pathologic Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intra-operative Mammography', 'description': "Intra-operative Specimen Mammography\n\nIntra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"}, {'id': 'OG001', 'title': 'Standard Mammography', 'description': 'Standard Specimen Mammography\n\nStandard Mammography: There is not an added device associated with this arm.'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Positive Predicitve Value', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Negative Predictive Value', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.\n\n* A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology\n* A false positive (FP) was defined as a positive margin by imaging but negative by pathology\n* A true negative (TN) was defined as a negative margin by both imaging and pathology.\n* A false negative (FN) was defined as a negative margin by imaging but positive by pathology\n* The sensitivity \\[TP/(TP + FN)\\], specificity \\[TN/(TN + FP)\\], positive predictive value \\[TP/ (TP + FP)\\], and negative predictive value \\[TN/(TN + FN)\\] for identification of positive margins were calculated for ISM and SSM.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intra-operative Mammography', 'description': "Intra-operative Specimen Mammography\n\nIntra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"}, {'id': 'FG001', 'title': 'Standard Mammography', 'description': 'Standard Specimen Mammography\n\nStandard Mammography: There is not an added device associated with this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intra-operative Mammography', 'description': "Intra-operative Specimen Mammography\n\nIntra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"}, {'id': 'BG001', 'title': 'Standard Mammography', 'description': 'Standard Specimen Mammography\n\nStandard Mammography: There is not an added device associated with this arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '79'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '78'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '38'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '46'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'description': "Body Mass Index is a weight to height ratio calculated by dividing someone's weight in Kg by the square of someone's height in meters.", 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Reason for excision', 'classes': [{'title': 'Excisional Biopsy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Atypia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Invasive Carcinoma/DCIS', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The indication for the excision:\n\n* An Excisional biopsy is a procedure where the entire abnormality or area of interest is removed.\n* Atypical Hyperplasia is a precancerous condition that is defined by an atypical accumulation of abnormal cells in the breast.\n* Ductal carcinoma in situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast. DCIS is considered the earliest form of breast cancer.\n* Invasive Carcinoma is a cancer that began growing in a duct in the breast and has since invaded the fatty tissue of the breast outside of the duct.', 'unitOfMeasure': 'Participants'}, {'title': 'Wire-localization Target', 'classes': [{'title': 'Clip', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Mass/ Calcs/ Arch distort', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A thin wire is inserted down to the target area of breast so that during surgery the surgeon can follow the guide wire down to the target area and remove the wire and the tissue around it. A clip is a marker that is placed in the breast during a biopsy that can be used a target for wire insertion. Mass means a solid mass in the breast. Calculated means that the target location was either manually or computer calculated. Architectural distortion (arch distort) is when a mammogram shows tethering or indentation of breast tissue but without an apparent associated mass.', 'unitOfMeasure': 'Participants'}, {'title': 'Anesthesia Type', 'classes': [{'title': 'MAC', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'General', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The type of anesthesia used during the procedure. Monitored anesthesia care (MAC) is when a patient undergoes local anesthesia together with sedation and analgesia. General anesthesia is anesthesia that affects the whole body and usually induces a loss of consciousness.', 'unitOfMeasure': 'Participants'}, {'title': 'Axillary Surgery', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'SLNB', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'ALND', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Type of axillary lymph node surgery\n\n* SLNB= Sentinel Lymph Node Biopsy\n* ALND= Axillary Lymph Node Dissection', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2013-01-08', 'resultsFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Operative Time Savings', 'timeFrame': 'At the time of the procedure (approximately 1 week after randomization)', 'description': 'To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Radiographic and Pathologic Findings', 'timeFrame': '2 years', 'description': 'Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.\n\n* A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology\n* A false positive (FP) was defined as a positive margin by imaging but negative by pathology\n* A true negative (TN) was defined as a negative margin by both imaging and pathology.\n* A false negative (FN) was defined as a negative margin by imaging but positive by pathology\n* The sensitivity \\[TP/(TP + FN)\\], specificity \\[TN/(TN + FP)\\], positive predictive value \\[TP/ (TP + FP)\\], and negative predictive value \\[TN/(TN + FN)\\] for identification of positive margins were calculated for ISM and SSM.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mammography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A breast biopsy in the operating room may be needed in up to 15% of patients with an abnormality on mammogram. When an abnormality is present but there is no palpable mass, the abnormality must be localized with a wire before going to the operating room. This technique is also used when a breast cancer is present but there is no mass, in order to perform a targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire is taken to the breast imaging department for a specimen x-ray to ensure that the targeted abnormality is present within the specimen. If the abnormality is close to the edge of the specimen, additional tissue is often removed.\n\nA newer method for evaluating the specimen is to perform imaging in the operating room. Portable digital mammography units are available for this purpose. The Biovision digital specimen mammography system is FDA-approved and currently in use in over 200 centers in the United States. Several studies have shown that intra-operative digital mammography is as accurate as standard specimen mammography and takes less time to perform. It may also decrease the chance of having to go back to the operating room to take more breast tissue after lumpectomy because of cancer cells near teh margin(s) of the specimen on final pathology. Having to go back to the operating room to take more tissue is called a re-excision.\n\nThe purpose of this study is to compare standard specimen mammography to intra-operative specimen mammography to quantify potential operating room time savings and to determine if the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if intra-operative specimen mammography is more efficient and if it decreases re-excision rates.', 'detailedDescription': 'Before the research starts patients will undergo some screening procedures to determine if patients are eligible to participate. This includes a medical history and an assessment of the patient\'s breast abnormality by mammogram and/or ultrasound and/or breast MRI. Patients will not need to undergo any extra procedures apart from those needed by the patient\'s surgeon to plan the patient\'s breast surgery. If the screening process shows that a patient is eligible to participate in this research study, the patient will be enrolled and the study will proceed on the day of surgery. If a patient does not meet the eligibility criteria the patient will not be able to participate in this research study.\n\nPatients will be assigned to one of two arms of this study on the day of your surgery. Because no one knows which of the breast specimen imaging options is best, patients will be "randomized" into one of the study groups: the Standard Specimen Mammography arm or, the Intra-operative Specimen Mammography arm. Randomization means that the patient is put into a group by chance. It is like flipping a coin. Neither the patient nor the surgeon will choose what group the patient will be in.\n\nIf the patient is in the Standard Specimen Mammography arm, the patient\'s breast specimen (biopsy or lumpectomy) will be taken to the Breast Imaging department for a mammogram, which is the way breast specimens are typically imaged. If the patient is in the Intra-Operative Specimen Mammography arm, the patient\'s breast specimen will be imaged right in the operating room at the time of the surgery. The patient\'s images will also be linked to the Breast Imaging department, so the radiologist can confirm the surgeon\'s findings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with a breast abnormality undergoing an excisional biopsy with wire localization or newly diagnosed with invasive breast cancer or ductal carcinoma undergoing a lumpectomy with wire localization\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Recurrent breast cancer\n* Palpable masses not requiring wire localization'}, 'identificationModule': {'nctId': 'NCT01766102', 'briefTitle': 'Intra-operative Digital vs. Standard Mammography', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography', 'orgStudyIdInfo': {'id': '12-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intra-operative Mammography', 'description': 'Intra-operative Specimen Mammography', 'interventionNames': ['Procedure: Intra-operative Mammography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Mammography', 'description': 'Standard Specimen Mammography', 'interventionNames': ['Procedure: Standard Mammography']}], 'interventions': [{'name': 'Intra-operative Mammography', 'type': 'PROCEDURE', 'otherNames': ['Biovision SN # 30042'], 'description': "The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042", 'armGroupLabels': ['Intra-operative Mammography']}, {'name': 'Standard Mammography', 'type': 'PROCEDURE', 'description': 'There is not an added device associated with this arm.', 'armGroupLabels': ['Standard Mammography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michelle Specht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle Specht', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}