Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05094102
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intraoperative Evaluation of Axillary Lymphatics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'neuman@surgery.wisc.edu', 'phone': '(608) 262-2025', 'title': 'Heather Neuman, MD, MS', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 1 day (day of surgery)', 'eventGroups': [{'id': 'EG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics'}], 'classes': [{'title': 'Visualized by Blue Dye', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Visualized by ICG', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 day (day of surgery)', 'description': 'This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics'}], 'classes': [{'title': 'Lymphatics spared by blue dye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lymphatics spared by ICG', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 day (day of surgery)', 'description': 'This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics'}], 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG]', 'description': 'A time curve of contrast-to-noise (CNR) ratio of lymphatic vessels to background tissue will be measured over the time frame of up to five minutes post-injection. The fluorescence signal intensity in both (1) the lymphatic vessels and in (2) the surrounding tissue will be measured in fluorescence arbitrary units. These two values will be aggregated to calculate and report the CNR, which is a unitless ratio. The maximum CNR will be reported.', 'unitOfMeasure': 'Maximum CNR Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at UW Hospital and Clinics from May 2022 to April 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nOnLume Imaging System: for fluorescence-guided surgery with ICG dye\n\nIndocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '30 to 39 years old', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '40 to 49 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '50 to 59 years old', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '60 to 69 years old', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '70 to 79 years old', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '80 to 89 years old', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-03', 'size': 788804, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-08T13:56', 'hasProtocol': True}, {'date': '2022-12-05', 'size': 211636, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-15T10:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2021-09-08', 'resultsFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-25', 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System', 'timeFrame': 'up to 1 day (day of surgery)', 'description': 'This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping'}, {'measure': 'Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System', 'timeFrame': 'up to 1 day (day of surgery)', 'description': 'This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping'}], 'secondaryOutcomes': [{'measure': 'Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal', 'timeFrame': 'Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG]', 'description': 'A time curve of contrast-to-noise (CNR) ratio of lymphatic vessels to background tissue will be measured over the time frame of up to five minutes post-injection. The fluorescence signal intensity in both (1) the lymphatic vessels and in (2) the surrounding tissue will be measured in fluorescence arbitrary units. These two values will be aggregated to calculate and report the CNR, which is a unitless ratio. The maximum CNR will be reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lymphedema', 'Surgery', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.', 'detailedDescription': 'Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk of arm lymphedema.\n\nIn this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.\n\nThe standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection\n* Surgery at University of Wisconsin Hospital and Clinic\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Unable to provide informed consent\n* Allergy to indocyanine green\n* Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy'}, 'identificationModule': {'nctId': 'NCT05094102', 'briefTitle': 'Intraoperative Evaluation of Axillary Lymphatics', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Intraoperative Evaluation of Axillary Lymphatics for Breast Cancer Patients Undergoing Axillary Surgery', 'orgStudyIdInfo': {'id': 'UW20058'}, 'secondaryIdInfos': [{'id': '2020-0939', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A539713', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/SURGERY/SURG ONC', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 11/3/2022', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '2R44CA206754-02A1', 'link': 'https://reporter.nih.gov/quickSearch/2R44CA206754-02A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axillary Surgery', 'description': 'Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.', 'interventionNames': ['Device: OnLume Imaging System', 'Drug: Indocyanine green']}], 'interventions': [{'name': 'OnLume Imaging System', 'type': 'DEVICE', 'description': 'for fluorescence-guided surgery with ICG dye', 'armGroupLabels': ['Axillary Surgery']}, {'name': 'Indocyanine green', 'type': 'DRUG', 'otherNames': ['ICG'], 'description': 'Indocyanine green is a cyanine dye used in medical diagnostics', 'armGroupLabels': ['Axillary Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Heather B Neuman, MD, MS, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'OnLume Inc.', 'class': 'INDUSTRY'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}