Axillary Reverse Mapping (ARM) Technique

Invasive Breast Cancer Clinical Trial

— ARM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03109522
• Other study ID #: TR-182
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2020

Study information

• Verified date: February 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ of the Breast
• Invasive Breast Cancer

Intervention

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.
• 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).

Locations

Country	Name	City	State
Canada	Juravinski Hospital and Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

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