Breast Cancer
Conditions
Keywords
Sentinel Lymph Node Biopsy, Axillary Node Dissection, Intraoperative Injection, Lumpectomy, Mastectomy
Brief summary
We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.
Detailed description
Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.
Interventions
PROCEDURESentinel Node Biopsy
Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
Sponsors
University of Arkansas
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
* Breast cancer requiring lymph node evaluation * Clinically negative lymph nodes in the axilla * Willing participation following an informed consent process
Exclusion criteria
* Patients with clinically positive lymph nodes * Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis) * Previous axillary lymphadenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To continue gathering data relating to the sentinel lymph node biopsy procedure. | Time of surgery and data analysis |
Secondary
| Measure | Time frame |
|---|---|
| To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. | Time of surgery and data analysis |
Countries
United States
Outcome results
None listed