Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
NCT02781259 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2016-09-20
Summary
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.
Conditions
- Breast Neoplasms
Interventions
- PROCEDURE
-
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.
- DRUG
-
Indocyanine green
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
- DEVICE
-
Imaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Principal Investigators
-
SeokWon Kim, MD. PhD. · Samsung Medical Center
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-04-30
Countries
- South Korea
Study Locations
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