University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205, United States
NCT Number: NCT00575744
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
Little Rock, Arkansas, 72205, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Axillary Node Dissection, Technitium Sulfur Colloid, Lymphazurin Blue Dye
Time frame: Time of surgery and data analysis
Time frame: Time of surgery and data analysis
University of Arkansas
Other
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