Axillary Reverse Mapping for Breast Cancer
(ARM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDaniela Ochoa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 100 years old.

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

Not pregnant or breastfeeding

+1 more

Exclusion Criteria

I am between 18 and 100 years old.

Pregnant or breastfeeding

If I am pregnant and diagnosed with breast cancer, I might still be eligible.

Participant Groups

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.

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