About this trial
Lymphedema is a devastating complication of breast cancer surgery that decreases the quality of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists have collaborated to refine a surgical technique known as LVB that may be used either as a preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB). Lymphatic reconstruction with LVB may be an improvement to the current standard of care for node positive breast cancer patients undergoing ALND.
Eligibility criteria
Qualifiers
Subjects must have histologically or cytologically confirmed axillary node positive unilateral breast cancer and may be female or male.
Subjects must have received no prior surgical interventions to the axilla except for core needle biopsy or sentinel node biopsy within 30 days of the planned axillary node dissection.
Age >18 years. Children are excluded from this study since breast cancer is quite rare in children.
ECOG Performance status 0 or 1
Disqualifiers
Contraindication to ICG as a) iodine hypersensitivity, b) renal failure, c) uremia and d) on dialysis.
Subjects receiving any prior surgical treatment or radiation to the axilla prior to protocol enrollment (except sentinel node biopsy within the past 30 days).
Subjects with known regional cervical or supraclavicular nodal disease or distant metastatic disease.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue dye or other agents used in this study.
Trial design
Treatments tested in this trial
- Axillary Lymph Node Dissection
- Axillary Reverse Mapping
- Lymphaticovenous Bypass