Axillary Reverse Mapping for Breast Cancer
(ARM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a technique called Axillary Reverse Mapping to assist breast cancer patients requiring lymph node evaluation. The goal is to map the arm's lymphatic system to avoid disrupting it during surgery, potentially reducing the risk of lymphedema (swelling due to fluid build-up). The study combines radioactivity and blue dye to visualize the lymphatic pathways. People with breast cancer who need lymph node checks or are undergoing a preventive mastectomy might be suitable candidates. Participants must agree to join after learning about the study and providing their consent. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that Axillary Reverse Mapping is safe for breast cancer patients?
Research has shown that axillary reverse mapping is safe for breast cancer patients. This technique helps prevent lymphedema, which is arm swelling that can occur after surgery. Although some patients undergoing axillary dissection may experience lymphedema, this mapping method aims to reduce that risk. Studies indicate that patients generally tolerate axillary reverse mapping well, with no major safety issues reported.12345
Why are researchers excited about this trial?
Researchers are excited about Axillary Reverse Mapping (ARM) because it offers a potential breakthrough in managing lymph nodes during breast cancer surgery. Unlike the standard approaches like Sentinel Lymph Node Biopsy and Full Axillary Lymph Node Dissection, which can lead to complications such as lymphedema, ARM aims to preserve the lymphatic drainage pathways. This innovative technique helps surgeons identify and protect crucial lymph nodes, reducing the risk of unnecessary damage. By minimizing side effects and improving recovery, ARM could significantly enhance the quality of life for breast cancer patients.
What evidence suggests that Axillary Reverse Mapping is effective for reducing lymphedema in breast cancer patients?
Research has shown that axillary reverse mapping (ARM) can reduce the risk of lymphedema, a condition where excess fluid accumulates in tissues, causing swelling after breast cancer surgery. In this trial, participants will be assigned to one of two treatment arms: one involving only a sentinel lymph node biopsy, and the other involving a full axillary lymph node dissection. Studies have found that with ARM, about 14% of patients who undergo removal of all lymph nodes under the arm experience lymphedema. This number drops to just 2% for those who have only a few lymph nodes removed, known as a sentinel lymph node biopsy. ARM helps maintain proper fluid drainage in the arm, which is crucial for preventing swelling. Research also confirms that ARM is safe for cancer treatment and can improve patients' quality of life.13467
Who Is on the Research Team?
Daniela Ochoa, MD
Principal Investigator
University of Arkansas
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Mapping of lymphatic drainage using technetium-99m sulfur colloid and blue dye during SLNB and/or ALND
Follow-up
Participants are monitored for the occurrence of lymphedema and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Axillary Reverse Mapping
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor