Axillary Reverse Mapping

Cancer of the Breast Clinical Trial

— ARM  

Official title:

ARM: Axillary Reverse Mapping, A Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00572481
• Other study ID #: 78076
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer of the Breast

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (5)

Boneti C, Badgwell B, Robertson Y, Korourian S, Adkins L, Klimberg V. Axillary reverse mapping (ARM): initial results of phase II trial in preventing lymphedema after lymphadenectomy. Minerva Ginecol. 2012 Oct;64(5):421-30. — View Citation

Boneti C, Korourian S, Bland K, Cox K, Adkins LL, Henry-Tillman RS, Klimberg VS. Axillary reverse mapping: mapping and preserving arm lymphatics may be important in preventing lymphedema during sentinel lymph node biopsy. J Am Coll Surg. 2008 May;206(5):1 — View Citation

Boneti C, Korourian S, Diaz Z, Santiago C, Mumford S, Adkins L, Klimberg VS. Scientific Impact Award: Axillary reverse mapping (ARM) to identify and protect lymphatics draining the arm during axillary lymphadenectomy. Am J Surg. 2009 Oct;198(4):482-7. doi — View Citation

Klimberg VS. A new concept toward the prevention of lymphedema: axillary reverse mapping. J Surg Oncol. 2008 Jun 1;97(7):563-4. doi: 10.1002/jso.20905. No abstract available. — View Citation

Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Westbrook KC, Klimberg VS. Axillary reverse mapping (ARM): a new concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007 Jun;14(6):1890-5. doi: 10.1245/s10434-007-9412-x. Epub 2007 May 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of lymphedema by the first year following surgery	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.	One year
Secondary	Successful identification (i.e., localization) of breast SLN and arm lymphatics	successful localization of one or more lymph nodes to which the peritumoral breast region drains	Time of surgery
Secondary	Characterization of location (typical versus variant) of arm lymphatics.	brief location details will also be collected.	Time of surgery
Secondary	Successful protection of the arm lymphatics during SLNB and/or ALND.	successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.	Time of surgery
Secondary	Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.	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.	Time of surgery