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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 belowSelect...
I am between 18 and 100 years old.
Select...
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
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 moreARM 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
486 Previous Clinical Trials
149,301 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 100 years old.I am between 18 and 100 years old.If I am pregnant and diagnosed with breast cancer, I might still be eligible.I need a lymph node check for breast cancer or am getting a preventive breast removal.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinel Lymph Node Biopsy Only
- Group 2: Full Axillary Lymph Node Dissection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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