Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Sentinel Node Biopsy

• Registration Number: NCT00575744
• Lead Sponsor: University of Arkansas

Brief 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.

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Primary Completion: 2010-10
• Study Completion: 2011-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 699

Inclusion Criteria

• Breast cancer requiring lymph node evaluation
• Clinically negative lymph nodes in the axilla
• Willing participation following an informed consent process

Exclusion Criteria

• Patients with clinically positive lymph nodes
• Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
• Previous axillary lymphadenectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sentinel Node Biopsy	-

Primary Outcome Measures

Name	Time	Method
To continue gathering data relating to the sentinel lymph node biopsy procedure.	Time of surgery and data analysis

Secondary Outcome Measures

Name	Time	Method
To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid.	Time of surgery and data analysis

Trial Locations

Locations (1)

University of Arkansas For Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States