Clinical trial · Interventional
Ultrasonographic Axillary Localization
Diagnostic Accuracy of Preoperative Ultrasonographic Tattooing of Suspicious Axillary Lymph Nodes in Breast Cancer Patients With Clinically Negative Axilla. A Prospective Cohort Study.
- 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)
Breast cancer is the most common cancer of women. Surgery for early breast cancer includes axillary lymph nodes staging. Axillary surgery may lead to intractable complications like permanent arm swelling. Axillary sentinel lymph node biopsy (SLNB) has been introduced to minimize the incidence of these complications. Several methods are routinely used for identification of the sentinel node during operation. Some of these methods necessitate facilities that are not universally available; specially in countries with limited resources. In its simplest form, SLNB using the methylene blue dye technique has an identification rate of 88-94%. If the sentinel node can not be identified, full axillary dissection may be required and the risk of arm swelling is increased. The objective of this study is to maximize the identification rate of the sentinel node thus avoiding the need for extensive axillary surgery. The investigators assumed that preoperative tattooing of the suspicious lymph node during ultrasonographical imaging may help the surgeon in localizing the sentinel lymph node. In this study, the sonographer will perform preoperative tattooing of the suspicious node. The surgeon will perform SLNB by the methylene blue dye. The sensitivity of ultrasonographical tattooing relative to SLNB will be calculated. The study will determine if the tattooing technique may localize additional nodes that are missed by the methylene blue.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Further axillary management | Procedure | — | UNRESOLVED |
| Histopathological examination of the axillary nodes | Diagnostic Test | — | UNRESOLVED |
| Sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| Ultrasonographical tattooing of suspicious axillary lymph nodes. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-sentinel node biopsy ultrasonographical tattooing
- description
- Preoperative ultrasonographical tattooing of the suspicious lymph nodes. Sentinel Lymph Node Biopsy (SLNB),
- interventionNames
- Diagnostic Test: Ultrasonographical tattooing of suspicious axillary lymph nodes.
- Procedure: Sentinel lymph node biopsy
- Diagnostic Test: Histopathological examination of the axillary nodes
- Procedure: Further axillary management
Primary outcomes (2)
- measure
- Sensitivity of ultrasonographical tattooing
- timeFrame
- at the date of surgery.
- description
- The ratio of the tattooed lymph nodes (that are positive by histopathological examination) to the sentinel lymph nodes (that are positive by histopathological examination).
- measure
- Identification benefit of the ultrasonographical tattooing.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven invasive breast adenocarcinoma. * Clinically non palpable axillary lymph nodes. * T0-3, N0, M0 * Scheduled for definitive surgery. Exclusion Criteria: * Patient unwilling to participate. * Contraindication to methylene blue technique: hypersensitivity, pregnancy. * T4 primary tumor. * Previous axillary surgery.
References
Publications (2)
- BACKGROUNDKim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Cheon H, Lee SM, Cho SH, Shin KM, Kim GC. Ultrasound-Guided Fine-Needle Aspiration of Non-palpable and Suspicious Axillary Lymph Nodes with Subsequent Removal after Tattooing: False-Negative Results and Concordance with Sentinel Lymph Nodes. Ultrasound Med Biol. 2017 Nov;43(11):2576-2581. doi: 10.1016/j.ultrasmedbio.2017.07.011. Epub 2017 Aug 19. PMID 28830644
- BACKGROUNDLi J, Chen X, Qi M, Li Y. Sentinel lymph node biopsy mapped with methylene blue dye alone in patients with breast cancer: A systematic review and meta-analysis. PLoS One. 2018 Sep 20;13(9):e0204364. doi: 10.1371/journal.pone.0204364. eCollection 2018. PMID 30235340