Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-03-14 @ 9:28 AM
Study NCT ID:
NCT02781259
Status:
UNKNOWN
Last Update Posted:
2016-09-20
First Post:
2016-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-18', 'studyFirstSubmitDate': '2016-05-08', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist', 'timeFrame': 'within 2 weeks (plus or minus 3 days) after surgery', 'description': 'Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.'}], 'secondaryOutcomes': [{'measure': 'Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes', 'timeFrame': 'within 2 weeks (plus or minus 3 days) after surgery', 'description': 'Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sentinel Lymph Node Biopsy', 'Fluorescence', 'Breast Neoplasms', 'Indocyanine Green'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.', 'detailedDescription': 'Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operable breast cancer patient\n* Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection\n\nExclusion Criteria:\n\n* Breast cancer history\n* Occult breast cancer\n* Past history of axillary surgery\n* Iodine hypersensitivity\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02781259', 'briefTitle': 'Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer', 'orgStudyIdInfo': {'id': '2015-01-046-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective Lymph Node Dissection', 'description': '10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.', 'interventionNames': ['Procedure: Axillary lymph node dissection', 'Drug: Indocyanine green', 'Device: Imaging devices']}], 'interventions': [{'name': 'Axillary lymph node dissection', 'type': 'PROCEDURE', 'description': 'Lymph node dissection is performed in axillary lymph node level I and II. In case of palpable nodes in level II, additional lymph node dissection in level III is done.', 'armGroupLabels': ['Selective Lymph Node Dissection']}, {'name': 'Indocyanine green', 'type': 'DRUG', 'otherNames': ['Diagnogreen'], 'description': '10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery', 'armGroupLabels': ['Selective Lymph Node Dissection']}, {'name': 'Imaging devices', 'type': 'DEVICE', 'description': 'Near-infrared fluorescence is collected by imaging lenses and digital camera.', 'armGroupLabels': ['Selective Lymph Node Dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SeokWon Kim, Md. PhD', 'role': 'CONTACT', 'email': 'seokwon1.kim@samsung.com', 'phone': '+82-2-3410-3479'}], 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'SeokWon Kim, MD. PhD.', 'role': 'CONTACT', 'email': 'seokwon1.kim@samsung.com', 'phone': '+82-2-3410-3479'}], 'overallOfficials': [{'name': 'SeokWon Kim, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Seok Won Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}