Clinical trial NCT00572481: Axillary Reverse Mapping
Official title: ARM: Axillary Reverse Mapping, a Prospective Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer of the Breast
Keywords: Sentinel Lymph Node Biopsy
Axillary Node Dissection
Prevention of lymphedema
Prevention of neuroma
Prevention of seroma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Occurrence of lymphedema by the first year following surgery
timeFrame: One year
Secondary outcomes:
measure: Successful identification (i.e., localization) of breast SLN and arm lymphatics
timeFrame: Time of surgery
measure: Characterization of location (typical versus variant) of arm lymphatics.
timeFrame: Time of surgery
measure: Successful protection of the arm lymphatics during SLNB and/or ALND.
timeFrame: Time of surgery
measure: Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.
timeFrame: Time of surgery
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Daniela Ochoa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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):1038-42; discussion 1042-4. doi: 10.1016/j.jamcollsurg.2007.12.022. Epub 2008 Mar 3.
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.
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: 10.1016/j.amjsurg.2009.06.008.
citation: 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.