Clinical trial · Interventional
Axillary Reverse Mapping for Invasive Carcinoma of the Breast
NCT00645541CI-TRIAL-00007710completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objectives: * To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy. * To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping. * To determine the safety of axillary reverse mapping.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Reverse Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axillary Reverse Mapping (ARM)
- interventionNames
- Procedure: Axillary Reverse Mapping
Primary outcomes (1)
- measure
- Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy
- timeFrame
- 2 years for overall study
- description
- Axillary reverse mapping (ARM) performed using 2 - 5cc of isosulfan blue, injected into the inner arm prior to skin incision for the axillary lymph node dissection. Blue channels identified during surgery and locations compared to axillary vein. Any blue nodes within the standard axillary lymph node dissection field removed then sent to pathology as a separate specimen labeled "axillary reverse mapping nodes" and evaluated with serial sectioning, and hematoxylin-eosin stain (H\&E) as well as immunohistochemistry.
Secondary outcomes (1)
- measure
- Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with invasive carcinoma of the breast planning to undergo axillary lymph node dissection at M. D. Anderson Cancer Center. * Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 3. Exclusion Criteria: * Patients with known allergies to blue dye or other contraindications to Lymphazurin.
References
Publications (0)
Data not yet available
No reference posted for this study.