Breast Cancer
Conditions
Keywords
Sentinel lymph node biopsy, Axillary lymph node dissection, Prevention of lymphedema
Brief summary
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
Detailed description
Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast. On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur \< 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.
Interventions
PROCEDUREInjection of isotope
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur \<3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios.
PROCEDUREAxillary lymph node dissection
The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is \<0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 - 100 years old * Not pregnant or breastfeeding * Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy * Willing participation after obtaining informed consent
Exclusion criteria
* \< 18 or \> 100 years of age * Pregnant or breastfeeding * Blue dye allergy * Cosmetic allergy * History of primary lymphedema * Prior breast augmentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess lymphedema rates | Four Years | The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of crossover | at time of surgery | Occurrence of crossover (i.e., co-localization) between hot breast sentinel lymph node and blue arm lymphatics |
| Identification of breast sentinal lymph node and arm lymphatics | at time of surgery | Successful identification (localization) of breast sentinel lymph node and arm lymphatics |
| Characterization of location | at time of surgery | Characterization of location (typical versus variant) of arm lymphatics |
| Protection of the arm | at time of surgery | Successful protection of the arm lymphatics during sentinel lymph node biopsy and/or axillary lymph node dissection |
Countries
United States
Outcome results
None listed