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Axillary Reverse Mapping (ARM) Technique (ARM)

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ClinicalTrials.gov Identifier: NCT03109522
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Peter Lovrics, McMaster University

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.

Condition or disease Intervention/treatment Phase
Invasive Breast Cancer Ductal Carcinoma in Situ of the Breast Procedure: axillary reverse mapping (ARM) Procedure: Standard axillary surgery (SLNB or ALND) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
Study Start Date : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Lymphedema [ Time Frame: Change from baseline to 6 months post-operative ]
    Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema

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


Secondary Outcome Measures :
  1. EORTC-QLQ-C30 [ Time Frame: Change from baseline to 6 months post-operative ]
    General quality of life

  2. EORTC-QLQ-C30 [ Time Frame: Change from baseline to 12 months post-operative ]
    General quality of life

  3. Disabilities of the Arm and Shoulder and Hand (DASH) [ Time Frame: Change from baseline to 6 months post-operative ]
    arm symptoms and disabilities

  4. Disabilities of the Arm and Shoulder and Hand (DASH) [ Time Frame: Change from baseline to 12 months post-operative ]
    arm symptoms and disabilities

  5. Post-operative complications [ Time Frame: 30 days post-op ]
    infection, hematoma, problems with wound healing

  6. Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 [ Time Frame: Change from baseline to 6 months post-operative ]
    arm symptoms and pain

  7. Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 [ Time Frame: Change from baseline to 12 months post-operative ]
    arm symptoms and pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109522


Contacts
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Contact: Peter Lovrics, MD 905-521-6060 lovricsp@mcmaster.ca
Contact: Sylvie Cornacchi, MSc 905-522-1155 ext 32411 cornacs@mcmaster.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Peter J Lovrics, MD    905-522-1155 ext 36060    lovricsp@mcmaster.ca   
Contact: Sylvie D Cornacchi, MSc    905-522-1155 ext 32411    cornacs@mcmaster.ca   
Principal Investigator: Peter J Lovrics, MD         
Juravinski Hospital and Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Nicole Hodgson, MD, MSc    905-575-6365    nhodgson@hhsc.ca   
Principal Investigator: Nicole Hodgson, MD, MSc         
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Peter Lovrics, MD McMaster University
Principal Investigator: Nicole Hodgson, MD, MSc McMaster University

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Responsible Party: Peter Lovrics, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT03109522     History of Changes
Other Study ID Numbers: TR-182
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peter Lovrics, McMaster University:
axillary reverse mapping (ARM)
sentinel lymph node biopsy (SLNB)
axillary lymph node dissection (ALND)
lymphedema
breast cancer
surgery

Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary