NCT00575744

Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 699 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1998-12-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2007-12-18
• Last updated: 2016-10-27

Locations

1 site across 1 country: United States