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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
Must not have
Patient < 18 y/o or > 100 y/o
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am between 18 and 100 years old.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of lymphedema by the first year following surgery
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
149,547 Total Patients Enrolled
17 Trials studying Breast Cancer
1,195 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
~9 spots leftby Feb 2025
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