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Spots Global Cancer Trial Database for Breast Lymph Node Mapping

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Breast Lymph Node Mapping

Official Title: Axillary Reverse Mapping in Breast Cancer

Study ID: NCT01038908

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mount Saint Joseph's Hospital, Vancouver, British Columbia, Canada

St. Paul's Hospital, Vancouver, British Columbia, Canada

Contact Details

Name: Sam Wiseman, MD, FRCSC, FACS

Affiliation: University of British Columbia

Role: PRINCIPAL_INVESTIGATOR

Name: Urve Kuusk, MD, FRCSC

Affiliation: University of British Columbia

Role: STUDY_DIRECTOR

Name: Carolyne Dingee, MD,FRCSC

Affiliation: University of British Columbia

Role: STUDY_DIRECTOR

Name: Elaine McKevitt, MD, FRCSC

Affiliation: University of British Columbia

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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