• Upper Extremity Lymphatic Mapping for Breast Cancer Patients

  NCT00717886

  CompletedInterventionalNot ApplicableUpdated Nov 20, 2015
• Axillary Reverse Mapping

  NCT00572481

  Active, not recruitingInterventionalPhase 2Updated Nov 6, 2025
• Axillary Reverse Mapping

  NCT01381315

  CompletedInterventionalPhase 2Updated Jan 10, 2017
• Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

  NCT03927027

  Active, not recruitingInterventionalPhase 3Updated Apr 21, 2026
• Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

  NCT00932035

  TerminatedInterventionalPhase 1Phase 2Updated Jun 7, 2017
• Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

  NCT01276054

  TerminatedInterventionalPhase 2Updated Aug 1, 2014

ClinicalTrials.gov ID

NCT01038908

Lead Sponsor

University of British ColumbiaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

100Estimated

Last Update Posted

Feb 15, 2013Estimated

Start Date

Jun 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

Official Title

Axillary Reverse Mapping in Breast Cancer

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.

• Breast Cancer

• Isosulfan Blue (Patent Blue Dye V)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University of British ColumbiaOTHER

smwiseman@providencehealth.bc.ca604-806-9108