Clinical trial · Observational
Reverse Axillary Mapping in Breast Radiation Treatment Planning
Reverse Axillary Mapping as a Lymphedema Prevention Strategy in Breast Radiation Treatment Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator decided not to move forward with the study
Summary
Brief summary (as posted)
The goal of this prospective study is to investigate the role of axillary reverse mapping (ARM) in radiation therapy planning of patients with breast cancer. Lymphedema is a common side effect after surgery and radiation therapy for breast cancer. The use of ARM is becoming more routine in surgery to differentiate the upper extremity lymphatics (UELs) from the breast axillary drainage to preferentially spare the UELs and reduce the rates of lymphedema.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Pts
- description
- Post-operative (lumpectomy or mastectomy) female breast cancer patients who will receive radiation to the whole breast or chest wall and the regional nodes.
Primary outcomes (1)
- measure
- Delineation of the upper extremity lymphatics (UEL) during the radiation treatment planning process using axillary reverse mapping (ARM)
- timeFrame
- Baseline to 1 year
- description
- ARM uses dye to track lymphatic flow of the upper extremities.We hypothesize that iodinated contrast injected into the upper inner arm (same site that surgeons inject during ARM) 15 minutes before the time of CT simulation will similarly be able to track the UELs. We will contour the visible iodinated dye and will measure if that anatomically correlates with the general known location of the UELs. Two radiation oncologists will independently determine if they can delineate the UELs. If both radiation oncologists can identify and contour the UELs in a reproducible fashion, we will code the patient as "UEL identified." If one or both physicians are either not able to identify the UEL on CT images or the contoured UEL structures are significantly different from each other, we will code the patient as "UEL not identified."
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * De novo presentation of post-operative (lumpectomy or mastectomy) female breast cancer patients to receive radiation to the whole breast or chest wall and the regional nodes. Patients who have received a sentinel lymph node (SLN) biopsy or an axillary lymph node dissection (ALND) will be eligible. * Greater than or equal to 18 years of age (no upper age limit). * Informed consent obtained. Exclusion Criteria: * Prisoners. * Patients with metastatic breast cancer. * Documented allergy to iodinated contrast * Prior breast or axillary surgeries or radiation.
References
Publications (0)
Data not yet available