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Axillary Reverse Mapping (ARM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572481
First Posted: December 13, 2007
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
  Purpose
We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.

Condition Intervention Phase
Cancer of the Breast Procedure: Axillary Reverse Mapping Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ARM: Axillary Reverse Mapping

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Occurrence of lymphedema by the first year following surgery [ Time Frame: One year ]
    An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.


Secondary Outcome Measures:
  • Successful identification (i.e., localization) of breast SLN and arm lymphatics [ Time Frame: Time of surgery ]
    successful localization of one or more lymph nodes to which the peritumoral breast region drains

  • Characterization of location (typical versus variant) of arm lymphatics. [ Time Frame: Time of surgery ]
    brief location details will also be collected.

  • Successful protection of the arm lymphatics during SLNB and/or ALND. [ Time Frame: Time of surgery ]
    successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.

  • Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics. [ Time Frame: Time of surgery ]
    A crossover event will consist of identification of one or more lymph nodes that are both focally radioactive following peritumoral Tc99m injection and noticeably stained blue following ipsilateral arm injection with Lymphazurin.


Estimated Enrollment: 1000
Study Start Date: May 2007
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sentinel Lymph Node Biopsy Only
Axillary Reverse Mapping
Procedure: Axillary Reverse Mapping
During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
Full Axillary Lymph Node Dissection
Axillary Reverse Mapping
Procedure: Axillary Reverse Mapping
During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.

Detailed Description:

Mapping Procedure:

Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.

If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.

If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps 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 either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-100 years old
  • Not pregnant or breastfeeding
  • Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy
  • Willing participation following an informed consent process

Exclusion Criteria:

  • Patient < 18 y/o or > 100 y/o
  • Pregnant or breastfeeding
  • If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572481


Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Daniela Ochoa, MD University of Arkansas
  More Information

Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00572481     History of Changes
Other Study ID Numbers: UAMS 78076
First Submitted: December 11, 2007
First Posted: December 13, 2007
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Arkansas:
Sentinel Lymph Node Biopsy
Axillary Node Dissection
Prevention of lymphedema
Prevention of neuroma
Prevention of seroma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases