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Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients
Sponsor: St. Antonius Hospital
Summary
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.
Official title: Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
493
Start Date
2023-06-08
Completion Date
2026-10
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
Phase I: Technetium is administered as single tracer to identify the SLN (current standard).
During this phase, surgeons will use technetium to identify the SLN as this is the current standard of care. This phase will serve as a control group.
Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)
During this phase, surgeons will primarily use ICG to identify the sentinel lymph node (SLN), while technetium will serve as a control. This approach allows surgeons to gain proficiency with ICG-guided SLN biopsy and safely advance through the learning curve.
Phase III: ICG is administered as single tracer to identify the SLN (alternative method).
During this phase, surgeons will use ICG as a singe tracer to identify the SLN.
Locations (11)
Ospedale Pederzoli
Peschiera del Garda, Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
FlevoZiekenhuis
Almere Stad, Netherlands
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Van Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Bernhoven Ziekenhuis
Uden, Netherlands
Isala Ziekenhuis
Zwolle, Netherlands