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Axillary Reverse Mapping (ARM) Technique (ARM)

Primary Purpose

Invasive Breast Cancer, Ductal Carcinoma in Situ of the Breast

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
axillary reverse mapping (ARM)
Standard axillary surgery (SLNB or ALND)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Breast Cancer focused on measuring axillary reverse mapping (ARM), sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphedema, breast cancer, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 -

Sites / Locations

  • St. Joseph's Healthcare
  • Juravinski Hospital and Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

axillary reverse mapping

standard axillary surgery

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Lymphedema
Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema
Lymphedema
Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema

Secondary Outcome Measures

EORTC-QLQ-C30
General quality of life
EORTC-QLQ-C30
General quality of life
Disabilities of the Arm and Shoulder and Hand (DASH)
arm symptoms and disabilities
Disabilities of the Arm and Shoulder and Hand (DASH)
arm symptoms and disabilities
Post-operative complications
infection, hematoma, problems with wound healing
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
arm symptoms and pain
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
arm symptoms and pain

Full Information

First Posted
October 27, 2016
Last Updated
February 19, 2020
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03109522
Brief Title
Axillary Reverse Mapping (ARM) Technique
Acronym
ARM
Official Title
A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
axillary reverse mapping
Arm Type
Experimental
Arm Description
Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)
Arm Title
standard axillary surgery
Arm Type
Active Comparator
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
axillary reverse mapping (ARM)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard axillary surgery (SLNB or ALND)
Intervention Description
The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).
Primary Outcome Measure Information:
Title
Lymphedema
Description
Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema
Time Frame
Change from baseline to 6 months post-operative
Title
Lymphedema
Description
Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema
Time Frame
Change from baseline to 12 months post-operative
Secondary Outcome Measure Information:
Title
EORTC-QLQ-C30
Description
General quality of life
Time Frame
Change from baseline to 6 months post-operative
Title
EORTC-QLQ-C30
Description
General quality of life
Time Frame
Change from baseline to 12 months post-operative
Title
Disabilities of the Arm and Shoulder and Hand (DASH)
Description
arm symptoms and disabilities
Time Frame
Change from baseline to 6 months post-operative
Title
Disabilities of the Arm and Shoulder and Hand (DASH)
Description
arm symptoms and disabilities
Time Frame
Change from baseline to 12 months post-operative
Title
Post-operative complications
Description
infection, hematoma, problems with wound healing
Time Frame
30 days post-op
Title
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
Description
arm symptoms and pain
Time Frame
Change from baseline to 6 months post-operative
Title
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
Description
arm symptoms and pain
Time Frame
Change from baseline to 12 months post-operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment: 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 - Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lovrics, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole Hodgson, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Juravinski Hospital and Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Axillary Reverse Mapping (ARM) Technique

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