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Breast Lymph Node Mapping

NCT01038908 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-02-15

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Sam Wiseman, MD, FRCSC, FACS · University of British Columbia

  • Urve Kuusk, MD, FRCSC · University of British Columbia

  • Carolyne Dingee, MD,FRCSC · University of British Columbia

  • Elaine McKevitt, MD, FRCSC · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038908 on ClinicalTrials.gov