Breast Lymph Node Mapping

February 12, 2013 updated by: University of British Columbia

Axillary Reverse Mapping in Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • Mount Saint Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Other: Isosulfan Blue (Patent Blue Dye V)
  1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
  2. Pre-incision: SLN is identified
  3. Inject blue dye into patient's arm
  4. Complete procedure (SLNB and/or ALND)
Other: Isosulfan Blue (Patent Blue Dye V)
  1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
  2. Pre-incision: SLN is not identified (No localization)
  3. Inject blue dye into breast (nothing in arm)

i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)
Active Comparator: 2
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.
Other: Isosulfan Blue (Patent Blue Dye V)
  1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
  2. Pre-incision: SLN is identified
  3. Inject blue dye into patient's arm
  4. Complete procedure (SLNB and/or ALND)
Other: Isosulfan Blue (Patent Blue Dye V)
  1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
  2. Pre-incision: SLN is not identified (No localization)
  3. Inject blue dye into breast (nothing in arm)

i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Map arm lymphatic drainage system in the axilla
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease the occurrence of lymphedema
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Sam Wiseman, MD, FRCSC, FACS, University of British Columbia
  • Study Director: Urve Kuusk, MD, FRCSC, University of British Columbia
  • Study Director: Carolyne Dingee, MD,FRCSC, University of British Columbia
  • Study Director: Elaine McKevitt, MD, FRCSC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H09-00926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Isosulfan Blue (Patent Blue Dye V)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe