Breast Lymph Node Mapping

Phase 2

• Conditions: Breast Cancer
• Interventions: Other: Isosulfan Blue (Patent Blue Dye V)

• Registration Number: NCT01038908
• Lead Sponsor: University of British Columbia

Brief Summary

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

Detailed Description

This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.

Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-15
• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 19-100 years old
2. Not pregnant or breastfeeding
3. Breast cancer requiring LN evaluation for the breast
4. Willing participation following an informed consent process

Exclusion Criteria

1. Patient < 19 y/o or > 100 y/o
2. Pregnant or breastfeeding
3. Allergy to blue dye
4. Locally advanced axillary disease
5. History of receiving neoadjuvant chemotherapy treatment
6. Prior axillary surgery or radiation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Isosulfan Blue (Patent Blue Dye V)	Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.
2	Isosulfan Blue (Patent Blue Dye V)	Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.

Primary Outcome Measures

Name	Time	Method
Map arm lymphatic drainage system in the axilla	4 years

Secondary Outcome Measures

Name	Time	Method
Decrease the occurrence of lymphedema	4 years

Trial Locations

Locations (2)

Mount Saint Joseph's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada