Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation|
- To continue gathering data relating to the sentinel lymph node biopsy procedure. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ]
- To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ]
|Study Start Date:||December 1998|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|No Intervention: 1||
Procedure: Sentinel 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575744
|United States, Arkansas|
|University of Arkansas For Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||V. Suzanne Klimberg, MD||University of Arkansas|