Axillary Reverse Mapping (ARM) Technique

McMaster University

Status: Unknown

Conditions: Ductal Carcinoma in Situ of the Breast; Invasive Breast Cancer

Treatments: Procedure: axillary reverse mapping (ARM); Procedure: Standard axillary surgery (SLNB or ALND)

Study type: Interventional

Funder types: Other

Identifiers

NCT03109522

TR-182

Details and patient eligibility

About

The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

Full description

Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment:

1. mastectomy and sentinel lymph node biopsy
2. breast conserving surgery or mastectomy and axillary lymph node dissection
3. completion axillary lymph node dissection after positive sentinel lymph node biopsy
4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment -

Exclusion Criteria:

1. males with breast cancer
2. women less than 18 years of age
3. known allergic reaction to patent blue dye
4. pregnant
5. previous radiation therapy to affected side
6. clinical N2/N3 disease -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

axillary reverse mapping

Experimental group

Description:

Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)

Treatment:

Procedure: axillary reverse mapping (ARM)

standard axillary surgery

Active Comparator group

Description:

The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

Treatment:

Procedure: Standard axillary surgery (SLNB or ALND)