A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
- Compare subareolar injection with peritumoral injection in identifying the sentinel
node during breast lymphatic mapping in patients with invasive breast cancer.
- Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with
subareolar injection vs peritumoral injection.
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur
colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30
minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive
technetium Tc 99m sulfur colloid by subareolar injection followed by another
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld
gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is
excised and the scheduled breast surgery is performed. If the sentinel node cannot be
identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Lymphatic drainage patterns as determined by peritumoral and subareolar injections
Evaluate outcome descriptively.
12 months to collect data
Gildy V. Babiera, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|