Clinical trial · Observational
ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer
- 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 value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG+Methylene Blue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ICG+Methylene Blue
- description
- ICG+Methylene Blue: Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery.
- interventionNames
- Procedure: ICG+Methylene Blue
Primary outcomes (1)
- measure
- Detection rate of SLN
- timeFrame
- Immediate
- description
- The number of successful SLNB / total number of SLNB
Secondary outcomes (2)
- measure
- False negative rate of SLNB
- timeFrame
- 1 week after the surgery
- description
- The number of patients with positive SLN / the number of patients with positive node
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients indicated for neoadjuvant therapy * Have complete evaluation of the axillary status * Planned for axillary clearance after neoadjuvant therapy Exclusion Criteria: * Sensitive to Iodine * Inflammatory disease * Patient's refusal to join the trial
References
Publications (3)
- BACKGROUNDKuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15. PMID 23683750
- BACKGROUNDBoughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932. PMID 24101169
- DERIVEDLiu M, Yang Y, Hua B, Feng R, Xu T, Wang M, Qi X, Cao Y, Zhou B, Tong F, Liu P, Liu H, Cheng L, Yang H, Xie F, Wang S, Wang C, Peng Y, Shen D, Chen L, Jiang J, Wang S. Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study. Thorac Cancer. 2025 Jan;16(2):e15511. doi: 10.1111/1759-7714.15511. Epub 2024 Dec 27. PMID 39731298