ARM: Axillary Reverse Mapping

Sponsor

University of Arkansas (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00572481

Collaborator

(none)

1,000

Enrollment

Location

Arms

193

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Breast	Procedure: Axillary Reverse Mapping	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

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.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, A Prospective Study

Study Start Date :

May 1, 2007

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: Sentinel Lymph Node Biopsy Only

Axillary Reverse Mapping

Procedure: Axillary Reverse Mapping

Other: Full Axillary Lymph Node Dissection

Axillary Reverse Mapping

Procedure: Axillary Reverse Mapping

Outcome Measures

Primary Outcome Measures

Occurrence of lymphedema by the first year following surgery [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 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 of surgery]
brief location details will also be collected.
Successful protection of the arm lymphatics during SLNB and/or ALND. [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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.