Axillary Reverse Mapping (ARM) Technique (ARM)

A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Invasive Breast Cancer; Ductal Carcinoma in Situ of the Breast
• Intervention / Treatment: Procedure: axillary reverse mapping (ARM); Procedure: Standard axillary surgery (SLNB or ALND)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Hospital and Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: axillary reverse mapping; Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)	Procedure: axillary reverse mapping (ARM); ARM/SLNB: patient will be injected with technetium-99 radiolabelled colloid (Tc-99) into the subareolar area of breast, then 1-2 mls of blue dye (patent blue dye) injected subcutaneously into the medial ipsilateral arm, just proximal to the medial epicondyle of the elbow, at the start of the surgical procedure. the SLN(s) will be identified ("hot node") and removed, and any blue lymph nodes and lymphatics will be preserved intact, and only removed or disrupted if there is 'crossover" (i.e. the blue node is also the SLN) or if clinically suspicious for metastatic disease. ARM/ALND: 1-2 mls of blue dye will be injected subcutaneously into the medial ipsilateral arm at the start of the surgical procedure. Surgeons will perform a standard level I and II axillary dissection and any blue lymph nodes or lymphatics will be preserved intact, and only removed or disrupted if blue nodes are suspicious for metastatic disease.
Active Comparator: standard axillary surgery; 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).	Procedure: Standard axillary surgery (SLNB or ALND); The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphedema	Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema	Change from baseline to 6 months post-operative
Lymphedema	Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema	Change from baseline to 12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC-QLQ-C30	General quality of life	Change from baseline to 6 months post-operative
EORTC-QLQ-C30	General quality of life	Change from baseline to 12 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)	arm symptoms and disabilities	Change from baseline to 6 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)	arm symptoms and disabilities	Change from baseline to 12 months post-operative
Post-operative complications	infection, hematoma, problems with wound healing	30 days post-op
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1	arm symptoms and pain	Change from baseline to 6 months post-operative
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1	arm symptoms and pain	Change from baseline to 12 months post-operative

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton; Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Peter Lovrics, MD, McMaster University; Principal Investigator: Nicole Hodgson, MD, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; surgery; lymphedema; sentinel lymph node biopsy (SLNB); axillary lymph node dissection (ALND); axillary reverse mapping (ARM)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: TR-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No