Invasive Breast CancerARMNCT03109522
Axillary Reverse Mapping (ARM) Technique
A study testing axillary reverse mapping (ARM) and Standard axillary surgery (SLNB or ALND) in people with Invasive Breast Cancer and Ductal Carcinoma in Situ of the Breast, run by McMaster University at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer, Ductal Carcinoma in Situ of the Breast
- What is being tested?
- axillary reverse mapping (ARM) and Standard axillary surgery (SLNB or ALND)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 5C2
About this study
Official title: 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.
Read the 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.
- Being tested
- axillary reverse mapping (ARM), Standard axillary surgery (SLNB or ALND)
- Keywords
- axillary reverse mapping (ARM), sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphedema, breast cancer, surgery
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary reverse mapping (ARM)Procedure or surgery
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)Procedure or surgery
The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Procedure: Standard axillary surgery (SLNB or ALND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema
Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema
Measured: 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
Measured: Change from baseline to 12 months post-operative
Secondary outcomes (7)
EORTC-QLQ-C30
General quality of life
Measured: Change from baseline to 6 months post-operative
EORTC-QLQ-C30
General quality of life
Measured: Change from baseline to 12 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)
arm symptoms and disabilities
Measured: Change from baseline to 6 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)
arm symptoms and disabilities
Measured: Change from baseline to 12 months post-operative
Post-operative complications
infection, hematoma, problems with wound healing
Measured: 30 days post-op
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
arm symptoms and pain
Measured: Change from baseline to 6 months post-operative
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
arm symptoms and pain
Measured: Change from baseline to 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startNov 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Peter Lovrics, McMaster University
- Investigators
- Peter Lovrics, MD, Principal investigator, McMaster UniversityNicole Hodgson, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109522
- Sponsor's protocol ID
- TR-182
- Acronym
- ARM
- Status last verified
- Feb 2020
- First submitted
- 27 Oct 2016
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT03109522
- Acronym / sponsor ID
- ARM / TR-182
- Keywords
- axillary reverse mapping (ARM), sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphedema, breast cancer, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| axillary reverse mapping | Experimental | Procedure: axillary reverse mapping (ARM)Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND) |
| standard axillary surgery | Active comparator | Procedure: Standard axillary surgery (SLNB or 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | axillary reverse mapping |
| 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). | Procedure or surgery | standard axillary surgery |
Primary outcome
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
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
7 secondary outcomes
EORTC-QLQ-C30
Time frame: Change from baseline to 6 months post-operative
EORTC-QLQ-C30
Time frame: Change from baseline to 12 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)
Time frame: Change from baseline to 6 months post-operative
Disabilities of the Arm and Shoulder and Hand (DASH)
Time frame: Change from baseline to 12 months post-operative
Post-operative complications
Time frame: 30 days post-op
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
Time frame: Change from baseline to 6 months post-operative
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
Time frame: Change from baseline to 12 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lovrics, MD principal investigator
McMaster University
Nicole Hodgson, MD, MSc principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary reverse mapping (ARM) and Standard axillary surgery (SLNB or ALND) in people with Invasive Breast Cancer and Ductal Carcinoma in Situ of the Breast, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema (time frame: Change from baseline to 6 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.