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Breast Lymph Node Mapping

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ClinicalTrials.gov Identifier: NCT01038908
Recruitment Status : Unknown
Verified February 2013 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2009
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Isosulfan Blue (Patent Blue Dye V) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Axillary Reverse Mapping in Breast Cancer
Study Start Date : June 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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Arms and Interventions
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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)
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 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)


Outcome Measures
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Primary Outcome Measures :
  1. Map arm lymphatic drainage system in the axilla [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Decrease the occurrence of lymphedema [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038908


Contacts
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Contact: Sam Wiseman, MD, FRCSC, FACS 604-806-9108 smwiseman@providencehealth.bc.ca

Locations
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Canada, British Columbia
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada
Contact: Sam Wiseman, MD, FRCSC, FACS    604-806-9108    smwiseman@providencehealth.bc.ca   
St. Paul's Hospital
Vancouver, British Columbia, Canada
Contact: Sam Wiseman, MD, FRCSC, FACS    604-806-9108    smwiseman@providencehealth.bc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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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
More Information
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01038908    
Other Study ID Numbers: H09-00926
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by University of British Columbia:
sentinel lymph node biopsy (SLNB)
axillary lymph node dissection (ALND)
lymphatics
blue dye
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases