Breast Lymph Node Mapping

NCT ID: NCT01038908

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Isosulfan Blue (Patent Blue Dye V)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Isosulfan Blue (Patent Blue Dye V)

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Wiseman, MD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Urve Kuusk, MD, FRCSC

Role: STUDY_DIRECTOR

University of British Columbia

Carolyne Dingee, MD,FRCSC

Role: STUDY_DIRECTOR

University of British Columbia

Elaine McKevitt, MD, FRCSC

Role: STUDY_DIRECTOR

University of British Columbia

Locations

Mount Saint Joseph's Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Sam Wiseman, MD, FRCSC, FACS

Role: CONTACT

smwiseman@providencehealth.bc.ca

604-806-9108

Facility Contacts

Sam Wiseman, MD, FRCSC, FACS

Role: primary

smwiseman@providencehealth.bc.ca

604-806-9108

Sam Wiseman, MD, FRCSC, FACS

Role: primary

smwiseman@providencehealth.bc.ca

604-806-9108

Other Identifiers

H09-00926

Identifier Type: -

Identifier Source: org_study_id