Axillary Reverse Mapping (ARM) Technique

NCT03109522 | Unknown DMC

• 1 other identifier: TR-182
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Invasive Breast Cancer; Ductal Carcinoma in Situ of the Breast

Keywords

axillary reverse mapping (ARM); sentinel lymph node biopsy (SLNB); axillary lymph node dissection (ALND); lymphedema; breast cancer; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• EORTC-QLQ-C30

  Change from baseline to 6 months post-operative

• EORTC-QLQ-C30

  Change from baseline to 12 months post-operative

• Disabilities of the Arm and Shoulder and Hand (DASH)

  Change from baseline to 6 months post-operative

• Disabilities of the Arm and Shoulder and Hand (DASH)

  Change from baseline to 12 months post-operative

• Post-operative complications

  30 days post-op

Study Arms (2)

axillary reverse mapping

EXPERIMENTAL

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)

standard axillary surgery

ACTIVE COMPARATOR

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)

Interventions

axillary reverse mapping (ARM) PROCEDURE

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.

axillary reverse mapping

Standard axillary surgery (SLNB or ALND) PROCEDURE

The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

standard axillary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• males with breast cancer
• women less than 18 years of age
• known allergic reaction to patent blue dye
• pregnant
• previous radiation therapy to affected side
• clinical N2/N3 disease -

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Lovrics, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Nicole Hodgson, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: April 12, 2017
• Study Start: November 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)