AzTrials
AzTrials

Cancer of the BreastPhase 2ARMNCT00572481

Axillary Reverse Mapping

A Phase 2 study testing Axillary Reverse Mapping in people with Cancer of the Breast, run by University of Arkansas at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of the Breast
What is being tested?
Axillary Reverse Mapping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
May 2007to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-100 years old
  • Not pregnant or breastfeeding
  • Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy
  • Willing participation following an informed consent process

Who cannot join

  • Patient < 18 y/o or > 100 y/o
  • Pregnant or breastfeeding
  • If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: ARM: Axillary Reverse Mapping, A Prospective Study

We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.

Read the detailed description

Mapping Procedure:

Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.

If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.

If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.

Being tested
Axillary Reverse Mapping
Keywords
Sentinel Lymph Node Biopsy, Axillary Node Dissection, Prevention of lymphedema, Prevention of neuroma, Prevention of seroma
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary Reverse MappingProcedure or surgery

    During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.

Study groups in NCT00572481
Study groupRoleWhat they receive
Sentinel Lymph Node Biopsy OnlyOtherAxillary Reverse Mapping
Receives: Procedure: Axillary Reverse Mapping
Full Axillary Lymph Node DissectionOtherAxillary Reverse Mapping
Receives: Procedure: Axillary Reverse Mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of lymphedema by the first year following surgery

    An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.

    Measured: One year

Secondary outcomes (4)

  1. Successful identification (i.e., localization) of breast SLN and arm lymphatics

    successful localization of one or more lymph nodes to which the peritumoral breast region drains

    Measured: Time of surgery

  2. Characterization of location (typical versus variant) of arm lymphatics.

    brief location details will also be collected.

    Measured: Time of surgery

  3. Successful protection of the arm lymphatics during SLNB and/or ALND.

    successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.

    Measured: Time of surgery

  4. Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.

    A crossover event will consist of identification of one or more lymph nodes that are both focally radioactive following peritumoral Tc99m injection and noticeably stained blue following ipsilateral arm injection with Lymphazurin.

    Measured: Time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Model description
During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572481
Sponsor's protocol ID
78076
Acronym
ARM
Status last verified
Nov 2025
First submitted
11 Dec 2007
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Westbrook KC, Klimberg VS. Axillary reverse mapping (ARM): a new concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007 Jun;14(6):1890-5. doi: 10.1245/s10434-007-9412-x. Epub 2007 May 4.

    PubMed 17479341

  • Klimberg VS. A new concept toward the prevention of lymphedema: axillary reverse mapping. J Surg Oncol. 2008 Jun 1;97(7):563-4. doi: 10.1002/jso.20905. No abstract available.

    PubMed 17955452

  • Boneti C, Korourian S, Bland K, Cox K, Adkins LL, Henry-Tillman RS, Klimberg VS. Axillary reverse mapping: mapping and preserving arm lymphatics may be important in preventing lymphedema during sentinel lymph node biopsy. J Am Coll Surg. 2008 May;206(5):1038-42; discussion 1042-4. doi: 10.1016/j.jamcollsurg.2007.12.022. Epub 2008 Mar 3.

    PubMed 18471751

  • Boneti C, Korourian S, Diaz Z, Santiago C, Mumford S, Adkins L, Klimberg VS. Scientific Impact Award: Axillary reverse mapping (ARM) to identify and protect lymphatics draining the arm during axillary lymphadenectomy. Am J Surg. 2009 Oct;198(4):482-7. doi: 10.1016/j.amjsurg.2009.06.008.

    PubMed 19800452

  • Boneti C, Badgwell B, Robertson Y, Korourian S, Adkins L, Klimberg V. Axillary reverse mapping (ARM): initial results of phase II trial in preventing lymphedema after lymphadenectomy. Minerva Ginecol. 2012 Oct;64(5):421-30.

    PubMed 23018481

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Axillary Reverse Mapping in people with Cancer of the Breast, run by University of Arkansas at 1 site in United States.

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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Occurrence of lymphedema by the first year following surgery (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00572481, which also lists 5 linked publications.

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 6 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in