Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments injection of isotope, axillary lymph node dissection
Phase phase 2
Sponsor University of Kansas Medical Center
Start date September 2009
End date May 2016
Trial size 211 participants
Trial identifier NCT01381315, 11737

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
injection of isotope
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.
(Other)
axillary lymph node dissection
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.

Primary Outcomes

Measure
Assess lymphedema rates
time frame: Four Years

Secondary Outcomes

Measure
Identification of breast sentinal lymph node and arm lymphatics
time frame: at time of surgery
Characterization of location
time frame: at time of surgery
Protection of the arm
time frame: at time of surgery
Occurrence of crossover
time frame: at time of surgery

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 18 - 100 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 Exclusion Criteria: - < 18 or > 100 years of age - Pregnant or breastfeeding - Blue dye allergy - Cosmetic allergy - History of primary lymphedema - Prior breast augmentation

Additional Information

Official title ARM: Axillary Reverse Mapping
Principal investigator Jamie Wagner, DO
Description Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast. 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. The site of all injections (radioactivity and/or blue dye) will be recorded.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.