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Procedure

Axillary Reverse Mapping for Breast Cancer (ARM Trial)

Phase 2

Waitlist Available

Led By Daniela Ochoa, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-100 years old

Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

ARM Trial Summary

This trial will test whether mapping the lymphatic drainage system of the arm during surgery can reduce the risk of developing lymphedema.

Who is the study for?

This trial is for adults aged 18-100 with breast cancer needing lymph node evaluation or those undergoing prophylactic mastectomy. Participants must not be pregnant, breastfeeding, and should consent to the study after being informed about it.Check my eligibility

What is being tested?

The trial tests Axillary Reverse Mapping (ARM) during sentinel lymph node biopsy or axillary lymph node dissection in breast cancer surgery. It uses radioactivity and blue dye to map arm lymphatics, aiming to prevent accidental damage and reduce the risk of developing lymphedema.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the blue dye or radioactive material used in ARM, localized skin changes at injection sites, and complications related to surgical procedures.

ARM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 100 years old.

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I need a lymph node check for breast cancer or am getting a preventive breast removal.

ARM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of lymphedema by the first year following surgery

Secondary outcome measures

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

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

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

+1 more

ARM Trial Design

2Treatment groups

Experimental Treatment

Group I: Sentinel Lymph Node Biopsy OnlyExperimental Treatment1 Intervention

Axillary Reverse Mapping

Group II: Full Axillary Lymph Node DissectionExperimental Treatment1 Intervention

Axillary Reverse Mapping

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axillary Reverse Mapping

2008

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

149,353 Total Patients Enrolled

18 Trials studying Breast Cancer

1,296 Patients Enrolled for Breast Cancer

Daniela Ochoa, MDPrincipal InvestigatorUniversity of Arkansas

1 Previous Clinical Trials

104 Total Patients Enrolled

1 Trials studying Breast Cancer

104 Patients Enrolled for Breast Cancer

Media Library

Axillary Reverse Mapping (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00572481 — Phase 2

Breast Cancer Research Study Groups: Sentinel Lymph Node Biopsy Only, Full Axillary Lymph Node Dissection

Breast Cancer Clinical Trial 2023: Axillary Reverse Mapping Highlights & Side Effects. Trial Name: NCT00572481 — Phase 2

Axillary Reverse Mapping (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00572481 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for enrollment in this research initiative?

"Clinicaltrials.gov reveals that this trial, which initially launched on May 1st 2007 and was last edited on the 3rd of January 2022, is not actively searching for participants at present. However, 2596 other trials are still looking to sign up volunteers in the current climate."

Answered by AI

Has this intervention been validated by the Federal Drug Administration?

"Our assessment of this intervention's safety has been ranked a 2, due to the fact that only Phase 2 data is available- meaning there are studies which have demonstrated its safe use but no evidence yet showing it as efficacious."

Answered by AI

Recent research and studies

The American Journal of SurgeryJournal

Scientific Impact Award: Axillary Reverse Mapping (ARM) to Identify and Protect Lymphatics Draining the Arm During Axillary Lymphadenectomy

Boneti, Cristiano, Soheila Korourian, Zuleika Diaz, Carlos Santiago, Sheila Mumford, Laura Adkins, and V. Suzanne Klimberg. 2009. “Scientific Impact Award: Axillary Reverse Mapping (ARM) to Identify and Protect Lymphatics Draining the Arm During Axillary Lymphadenectomy”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2009.06.008.

Journal of Surgical OncologyJournal

A New Concept Toward the Prevention of Lymphedema: Axillary Reverse Mapping

Klimberg, V. Suzanne. 2008. “A New Concept Toward the Prevention of Lymphedema: Axillary Reverse Mapping”. Journal of Surgical Oncology. Wiley. doi:10.1002/jso.20905.

Annals of Surgical OncologyJournal

Axillary Reverse Mapping (ARM): A New Concept to Identify and Enhance Lymphatic Preservation

Thompson, Margaret, Soheila Korourian, Ronda Henry-Tillman, Laura Adkins, Sheilah Mumford, Kent C. Westbrook, and V Suzanne Klimberg. 2007. “Axillary Reverse Mapping (ARM): A New Concept to Identify and Enhance Lymphatic Preservation”. Annals of Surgical Oncology. Springer Science and Business Media LLC. doi:10.1245/s10434-007-9412-x.

Journal of the American College of SurgeonsJournal