Breast Lymph Node Mapping

NCT01038908 | Unknown Phase 2

• 1 other identifier: H09-00926
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

sentinel lymph node biopsy (SLNB); axillary lymph node dissection (ALND); lymphatics; blue dye

Outcome Measures

Primary Outcomes (1)

• Map arm lymphatic drainage system in the axilla

  4 years

Secondary Outcomes (1)

• Decrease the occurrence of lymphedema

  4 years

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

ACTIVE COMPARATOR

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)

Interventions

Isosulfan Blue (Patent Blue Dye V) OTHER

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)

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Not pregnant or breastfeeding
• Breast cancer requiring LN evaluation for the breast
• Willing participation following an informed consent process

You may not qualify if:

• Patient \< 19 y/o or \> 100 y/o
• Pregnant or breastfeeding
• Allergy to blue dye
• Locally advanced axillary disease
• History of receiving neoadjuvant chemotherapy treatment
• Prior axillary surgery or radiation therapy

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Mount Saint Joseph's Hospital

Vancouver, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

iso-sulfan blue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sam Wiseman, MD, FRCSC, FACS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Sam Wiseman, MD, FRCSC, FACS

CONTACT

604-806-9108; smwiseman@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CA (2)