Clinical trial · Interventional
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope
Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.
- 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 aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.
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 |
|---|---|---|---|
| Infiltrative Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anatomo-pathologic procedure | Procedure | — | UNRESOLVED |
| Methylene blue (1%) | Drug | — | UNRESOLVED |
| Rhenium sulfure | Drug | — | UNRESOLVED |
| Surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
Secondary outcomes (2)
- measure
- Comparison of the results of SLN serial sectioning, with H&E and IHC staining
- measure
- Economical evaluation of SLN procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy) * approval and informed consent Exclusion Criteria: * chemotherapy * locoregional radiotherapy * prevalent axillary lymph node
References
Publications (1)
- RESULTMathelin C, Croce S, Brasse D, Gairard B, Gharbi M, Andriamisandratsoa N, Bekaert V, Francis Z, Guyonnet JL, Huss D, Salvador S, Schaeffer R, Grucker D, Marin C, Bellocq JP. Methylene blue dye, an accurate dye for sentinel lymph node identification in early breast cancer. Anticancer Res. 2009 Oct;29(10):4119-25. PMID 19846959