Clinical trial · Interventional
Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients
Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation 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)
This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and potential side effects. Extensive research indicates that Indocyanine Green (ICG) is an equally effective and potentially more practical alternative. Conducting this study will help accelerate the implementation of ICG in clinical practice.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase III: ICG is administered as single tracer to identify the SLN (alternative method). | Procedure | — | UNRESOLVED |
| Phase II: SLN biopsy using double tracer technetium and ICG (learning curve) | Procedure | — | UNRESOLVED |
| Phase I: Technetium is administered as single tracer to identify the SLN (current standard). | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Phase I: pre-implemtation phase
- description
- SLN biopsy using single tracer techentium (current standard)
- interventionNames
- Procedure: Phase I: Technetium is administered as single tracer to identify the SLN (current standard).
- type
- OTHER
- label
- Phase II: transition phase
- description
- SLN biopsy using double tracer technetium and ICG (learning curve)
- interventionNames
- Procedure: Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)
- type
- OTHER
- label
- Phase III: post-implementation phase
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically node-negative, DCIS or invasive breast cancer confirmed by biopsy * Preoperative axillary ultrasound to confirm clinical node-negative status * Indication for breast cancer surgery with SLNB via axillar incision * Written informed consent according to ICH/GCP and national regulations. Exclusion Criteria: * Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Combined MARI procedure * Known allergy for Indocyanine Green (ICG) or intravenous contrast or iodine * History of axillary lymph node dissection * Hyperthyroidism or thyroid cancer * Pregnancy or breast-feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
References
Publications (0)
Data not yet available