NCT01381315

Brief Summary

It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

6.7 years

First QC Date

June 9, 2011

Last Update Submit

January 6, 2017

Conditions

Breast Cancer

Keywords

Sentinel lymph node biopsyAxillary lymph node dissectionPrevention of lymphedema

Outcome Measures

Primary Outcomes (1)

  • Assess lymphedema rates

    The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.

    Four Years

Secondary Outcomes (4)

  • Identification of breast sentinal lymph node and arm lymphatics

    at time of surgery

  • Characterization of location

    at time of surgery

  • Protection of the arm

    at time of surgery

  • Occurrence of crossover

    at time of surgery

Study Arms (2)

Sentinel lymph node biopsy

OTHER

During surgery, 1.0 mCi of technetium-99m sulfur colloid will be injected into sub-dermal subareolar aspect of the affected breast. The KUMC Nuclear Medicine Department will be responsible for performing the injection of the isotope and dilution of the isotope using saline to a final volume of 4.0 ml or less.

Procedure: Injection of isotope

Axillary lymph node biopsy

OTHER
Procedure: Axillary lymph node dissection

Interventions

Injection of isotopePROCEDURE

On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur \<3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios.

Sentinel lymph node biopsy
Axillary lymph node dissectionPROCEDURE

The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is \<0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.

Axillary lymph node biopsy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Not pregnant or breastfeeding
  • Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
  • Willing participation after obtaining informed consent

You may not qualify if:

  • \< 18 or \> 100 years of age
  • Pregnant or breastfeeding
  • Blue dye allergy
  • Cosmetic allergy
  • History of primary lymphedema
  • Prior breast augmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jamie Wagner, DO

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 27, 2011

Study Start

September 1, 2009

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)