Clinical trial · Interventional
Second Echelon Node Study With Methylene Blue
Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
NCT01823172CI-TRIAL-00032218completedN/AClinicalTrials.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)
The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.
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 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylene blue dye injection of sentinel lymph node | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Methylene Blue
- description
- 1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node
- interventionNames
- Procedure: Methylene blue dye injection of sentinel lymph node
Primary outcomes (1)
- measure
- The number of subjects in whom a secondary echelon lymph node is identified
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary cutaneous melanoma located on the extremity or trunk * Patients with clinically stage I-II melanoma * Histologically confirmed invasive ductal or lobular carcinoma * Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative Exclusion Criteria: * Melanoma located on the head or neck, uveal or mucosal * Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin * Preoperative biopsy proven regional lymph node involvement * Failure of lymphatic mapping with radioactive colloid * Women who are pregnant or nursing * Prior ipsilateral axillary surgery or radiation * Inflammatory breast cancer * No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen * Stage IV breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.