The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
62
1 mC1
University Medical Center
Lafayette, Louisiana, United States
LSU Interim Hospital
New Orleans, Louisiana, United States
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)
Time frame: intraoperatively; up to 6 hours
Safety (Allergic Reaction to Blue Dye)
number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension
Time frame: intraoperatively up to 6 hours
Superficial Skin Necrosis
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
Time frame: 2 weeks postoperatively
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