Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
NCT ID: NCT02781259
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2016-05-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Selective Lymph Node Dissection
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.
Axillary lymph node dissection
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.
Indocyanine green
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
Imaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.
Interventions
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Axillary lymph node dissection
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.
Indocyanine green
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
Imaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection
Exclusion Criteria
* Occult breast cancer
* Past history of axillary surgery
* Iodine hypersensitivity
* Pregnancy
20 Years
70 Years
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Seok Won Kim
Associate professor
Principal Investigators
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SeokWon Kim, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung medical center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-01-046-007
Identifier Type: -
Identifier Source: org_study_id
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