Axillary Reverse Mapping for Breast Cancer

(ARM Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arkansas

Disqualifiers: Pregnant, Breastfeeding, Age restrictions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Axillary Reverse Mapping for breast cancer?

Research suggests that axillary reverse mapping (ARM) may help preserve arm lymphatics during breast cancer surgery, potentially reducing the risk of lymphedema (swelling due to lymph fluid buildup). Studies indicate that ARM is feasible and may be oncologically safe, especially in early-stage breast cancer patients. ^{1 2 3 4 5}

Is Axillary Reverse Mapping safe for humans?

Axillary Reverse Mapping (ARM) is a technique used in breast cancer surgery to help prevent lymphedema (swelling due to lymph fluid buildup) by preserving arm lymphatics. While it aims to reduce the risk of lymphedema, the overall safety, especially regarding cancer outcomes, is still being studied and debated. ^{2 6 7 8 9}

How is axillary reverse mapping treatment different from other breast cancer treatments?

Axillary reverse mapping (ARM) is unique because it aims to preserve the lymphatic drainage of the arm during breast cancer surgery, potentially reducing the risk of lymphedema (swelling due to lymph fluid buildup) compared to traditional axillary lymph node dissection, which does not differentiate between arm and breast lymphatics. ^{1 3 5 10 11}

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.

Research Team

Daniela Ochoa, MD

Principal Investigator

University of Arkansas

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

Not pregnant or breastfeeding

Willing participation following an informed consent process

Exclusion Criteria

Pregnant or breastfeeding

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Mapping of lymphatic drainage using technetium-99m sulfur colloid and blue dye during SLNB and/or ALND

Time of surgery

1 visit (in-person)

Follow-up

Participants are monitored for the occurrence of lymphedema and other outcomes

One year

Treatment Details

Interventions

• Axillary Reverse Mapping

Trial Overview 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.

Participant Groups

Group I: Sentinel Lymph Node Biopsy Only Experimental Treatment 1 Intervention

Axillary Reverse Mapping

Group II: Full Axillary Lymph Node Dissection Experimental Treatment 1 Intervention

Axillary Reverse Mapping

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Extensive nodal disease may impair axillary reverse mapping in patients with breast cancer. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Axillary Reverse Mapping in the Prevention of Lymphoedema: A Systematic Review and Pooled Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Clinical impact of breast MRI with regard to axillary reverse mapping in clinically node positive breast cancer patients following neo-adjuvant chemotherapy. [2016]

4. Egypt pubmed.ncbi.nlm.nih.gov

Application of Fluorescence Dye in Combination with Methylene Blue for Axillary Reverse Mapping in Patients with Modified Radical Mastectomy for Breast Cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A phase I study to assess the feasibility and oncologic safety of axillary reverse mapping in breast cancer patients. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Axillary reverse mapping using a fluorescence imaging system in breast cancer. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review of axillary reverse mapping in breast cancer. [2018]

8. Greece pubmed.ncbi.nlm.nih.gov

Feasibility and Oncological Safety of Axillary Reverse Mapping in Patients With Locally Advanced Breast Cancer and Partial Response After Neoadjuvant Chemotherapy. [2021]

9. Greece pubmed.ncbi.nlm.nih.gov

Neoadjuvant Treatment as a Risk Factor for Variation of Upper Limb Lymph Node Drainage During Axillary Reverse Mapping in Breast Cancer: A Prospective Observational Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Axillary reverse mapping in patients with breast cancer: Is it oncologically safe? [2017]

11. England pubmed.ncbi.nlm.nih.gov

ARM: axillary reverse mapping - the need for selection of patients. [2012]