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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosulfan Blue (Patent Blue Dye V) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Map arm lymphatic drainage system in the axilla | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease the occurrence of lymphedema | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sam Wiseman, MD, FRCSC, FACS | Contact | 604-806-9108 | smwiseman@providencehealth.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sam Wiseman, MD, FRCSC, FACS | University of British Columbia | Principal Investigator |
| Urve Kuusk, MD, FRCSC | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Saint Joseph's Hospital | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C025484 | iso-sulfan blue |
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| Isosulfan Blue (Patent Blue Dye V) | Other |
i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND) |
|
| Carolyne Dingee, MD,FRCSC |
| University of British Columbia |
| Study Director |
| Elaine McKevitt, MD, FRCSC | University of British Columbia | Study Director |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
|
| D017437 |
| Skin and Connective Tissue Diseases |