Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients
NCT ID: NCT07311278
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
493 participants
INTERVENTIONAL
2023-06-08
2026-10-31
Brief Summary
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Detailed Description
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Currently, the gold standard for SLN localization is the use of Technetium-99m (99mTc). However, this method has several disadvantages. Since not every hospital has a Nuclear Medicine Department, patients often need to be referred to another facility for 99mTc injection and nuclear imaging. This process can be burdensome for patients and poses logistical challenges when scheduling surgeries. In addition, the use of 99mTc involves exposure to radioactive material, and adverse effects such as allergic reactions have been reported. Recent studies have shown that the use of Indocyanine Green (ICG) is equally effective for sentinel lymph node localization as Technetium.
The aim of this study is to evaluate the national and international implementation process of a new diagnostic method for SLN detection.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Phase I: pre-implemtation phase
SLN biopsy using single tracer techentium (current standard)
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: transition phase
SLN biopsy using double tracer technetium and ICG (learning curve)
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: post-implementation phase
SLN biopsy using single tracer ICG (alternative method)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Antonius Hospital
OTHER
Responsible Party
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Tessa Dinger
Medical Doctor
Locations
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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
Countries
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Other Identifiers
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NL79223.100.22
Identifier Type: -
Identifier Source: org_study_id