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Axillary Reverse Mapping (ARM)

Primary Purpose

Cancer of the Breast

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Axillary Reverse Mapping
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of the Breast focused on measuring Sentinel Lymph Node Biopsy, Axillary Node Dissection, Prevention of lymphedema, Prevention of neuroma, Prevention of seroma

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Arkansas For Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sentinel Lymph Node Biopsy Only

Full Axillary Lymph Node Dissection

Arm Description

Axillary Reverse Mapping

Axillary Reverse Mapping

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Characterization of location (typical versus variant) of arm lymphatics.
brief location details will also be collected.
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.
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.

Full Information

First Posted
December 11, 2007
Last Updated
August 3, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00572481
Brief Title
Axillary Reverse Mapping
Acronym
ARM
Official Title
ARM: Axillary Reverse Mapping, A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Breast
Keywords
Sentinel Lymph Node Biopsy, Axillary Node Dissection, Prevention of lymphedema, Prevention of neuroma, Prevention of seroma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel Lymph Node Biopsy Only
Arm Type
Other
Arm Description
Axillary Reverse Mapping
Arm Title
Full Axillary Lymph Node Dissection
Arm Type
Other
Arm Description
Axillary Reverse Mapping
Intervention Type
Procedure
Intervention Name(s)
Axillary Reverse Mapping
Intervention 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.
Primary Outcome Measure Information:
Title
Occurrence of lymphedema by the first year following surgery
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Successful identification (i.e., localization) of breast SLN and arm lymphatics
Description
successful localization of one or more lymph nodes to which the peritumoral breast region drains
Time Frame
Time of surgery
Title
Characterization of location (typical versus variant) of arm lymphatics.
Description
brief location details will also be collected.
Time Frame
Time of surgery
Title
Successful protection of the arm lymphatics during SLNB and/or ALND.
Description
successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.
Time Frame
Time of surgery
Title
Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.
Description
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.
Time Frame
Time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ochoa, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas For Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17479341
Citation
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.
Results Reference
background
PubMed Identifier
17955452
Citation
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.
Results Reference
background
PubMed Identifier
18471751
Citation
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.
Results Reference
result
PubMed Identifier
19800452
Citation
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.
Results Reference
result
PubMed Identifier
23018481
Citation
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.
Results Reference
result

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Axillary Reverse Mapping

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