Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-17 @ 8:41 PM
Study NCT ID:
NCT01544335
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2012-02-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of BIS for Quantification of Lymphedema
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': 'cbrunelle@mgh.harvard.edu', 'phone': '6177240127', 'title': 'Associate Director, Lymphedema Research Program', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 years', 'eventGroups': [{'id': 'EG000', 'title': 'Bioimpedance Spectroscopy', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy\n\nBioimpedance Spectroscopy: BIS used to measure fluid in arm', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 0, 'seriousNumAtRisk': 191, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}, {'units': 'measurements', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioimpedance Sprectroscopy', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy\n\nBioimpedance Spectroscopy: BIS used to measure fluid in arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.195', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Correlation coefficient', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.'}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'measurements', 'denomUnitsSelected': 'measurements', 'populationDescription': '53 of the 191 participants had to be excluded. 27 lost to follow up, 4 died on the study, 3 had disease progression, and baseline measurements were not available for 19 participants.'}, {'type': 'SECONDARY', 'title': 'Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioimpedance Sprectroscopy', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy\n\nBioimpedance Spectroscopy: BIS used to measure fluid in arm'}], 'timeFrame': '5 years', 'description': 'Relationship among diagnostic criteria pertaining to BIS, perometry, and self-reported symptoms. A change of \\>3 Standard Deviations in impedance ratios compared to pre-surgical baseline is considered diagnostic for lymphedema when BIS is utilized. A relative volume change of \\>5% - \\>10% compared to baseline is considered lymphedema by perometry. Self-report of symptoms including feelings of swelling, heaviness, and tightness are often considered as criteria for lymphedema.', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was not collected and outcome cannot be reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bioimpedance Sprectroscopy', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy\n\nBioimpedance Spectroscopy: BIS used to measure fluid in arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Baseline Measurements not Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}], 'preAssignmentDetails': '270 participants were accrued, however 65 had to be excluded because they later received bilateral breast surgery and 14 withdrew consent. This is why 191 participants started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bioimpedance Spectroscopy', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy\n\nBioimpedance Spectroscopy: BIS used to measure fluid in arm'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'BG000', 'lowerLimit': '27.2', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '138', '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': '138', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants included in analysis who had at least one post-operative follow up measurement'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 1069681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-16T12:58', 'hasProtocol': True}, {'date': '2019-03-04', 'size': 331834, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-16T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2012-02-12', 'resultsFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-15', 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)', 'timeFrame': '5 years', 'description': 'Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.'}], 'secondaryOutcomes': [{'measure': 'Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms', 'timeFrame': '5 years', 'description': 'Relationship among diagnostic criteria pertaining to BIS, perometry, and self-reported symptoms. A change of \\>3 Standard Deviations in impedance ratios compared to pre-surgical baseline is considered diagnostic for lymphedema when BIS is utilized. A relative volume change of \\>5% - \\>10% compared to baseline is considered lymphedema by perometry. Self-report of symptoms including feelings of swelling, heaviness, and tightness are often considered as criteria for lymphedema.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34506083', 'type': 'BACKGROUND', 'citation': 'Gillespie TC, Roberts SA, Brunelle CL, Bucci LK, Bernstein MC, Daniell KM, Naoum GN, Miller CL, Taghian AG. Comparison of perometry-based volumetric arm measurements and bioimpedance spectroscopy for early identification of lymphedema in a prospectively-screened cohort of breast cancer patients. Lymphology. 2021;54(1):1-11.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34506083/', 'label': 'Gillespie 2021 Publication Link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether measuring the fluid in your arms using Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as measurements with the Perometer. The investigators will also evaluate any symptoms you may experience in your arms during and after treatment for breast cancer with a questionnaire.', 'detailedDescription': 'During the study whenever you have an arm volume measurement using the Perometer, we will also measure the fluid in your arms using Bioimpedance Spectroscopy. These measurements are made by passing a harmless electrical signal of very low strength through your body to determine the difference in the amount of fluid in each arm. The test is simple and painless, and takes about 3 minutes. In addition, whenever you have an arm measurement, you will be asked to complete a questionnaire. While completing the questionnaire, you can skip any questions you do not wish to answer. The questionnaires will take about 10 minutes to complete. Arm measurements with the Perometer and Bioimpedance Spectroscopy and completion of the questionnaire will occur every 4-7 months when you are at MGH for regular medical visits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with histologically or cytologically confirmed breast cancer who will be returning routinely for follow-up at Massachusetts General Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed invasive or in-situ carcinoma of the breast\n* Participants must have undergone sentinel node mapping or axillary dissection\n* Life expectancy of greater than 1 year.\n* Willingness to comply with required follow up Perometer and BIS measurements and completion of LEFT-BC questionnaire\n\nExclusion Criteria:\n\n* Patients who have known metastatic disease or other locally advanced disease in the thoracic or cervical regions\n* Any patient who will not be returning routinely for follow-up at MGH or DFHCC\n* Participants with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* History of primary lymphedema\n* History of prior surgery or radiation to the head, neck, upper limb, or trunk\n* Participants who have evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion\n* Any patient who has bilateral lymph node mapping or dissection\n* Any patient with a current case of cellulitis\n* Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT01544335', 'briefTitle': 'Evaluation of BIS for Quantification of Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report', 'orgStudyIdInfo': {'id': '11-325'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BIS', 'description': 'Subjects evaluated using Bioimpedance Spectroscopy', 'interventionNames': ['Other: Bioimpedance Spectroscopy']}], 'interventions': [{'name': 'Bioimpedance Spectroscopy', 'type': 'OTHER', 'description': 'BIS used to measure fluid in arm', 'armGroupLabels': ['BIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alphonse Taghian', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}