Breast Neoplasms
Conditions
Keywords
Sentinel Lymph Node Biopsy, Fluorescence, Breast Neoplasms, Indocyanine Green
Brief 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.
Detailed description
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.
Interventions
PROCEDUREAxillary 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.
DRUGIndocyanine green
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
DEVICEImaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Operable breast cancer patient * Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection
Exclusion criteria
* Breast cancer history * Occult breast cancer * Past history of axillary surgery * Iodine hypersensitivity * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist | within 2 weeks (plus or minus 3 days) after surgery | Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes | within 2 weeks (plus or minus 3 days) after surgery | Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis |
Countries
South Korea
Contacts
Primary ContactSeokWon Kim, MD. PhD.
Outcome results
None listed