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.
An important part of oncological treatment for breast cancer is determining the lymph node status. A commonly used method for this is the sentinel lymph node (SLN) procedure. Analysis of this node plays a key role in determining both treatment and prognosis. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
493
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.
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.
Ospedale Pederzoli
Peschiera del Garda, Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
FlevoZiekenhuis
Almere Stad, Netherlands
Antoni van Leeuwenhoek Ziekenhuis
Identifaction rate
Identification rate is defined as the proportion of patients in whom lymph nodes were identified with the gamma-probe using technetium or the fluorescent signal of ICG.
Time frame: Perioperatively
Number of lymph nodes identified
This indicates the total number of lymph nodes identified with ICG or technetium.
Time frame: Perioperatively
Percentage of SLNs identified per tracer
Percentage of SLNs that had technetium uptake / were fluorescent.
Time frame: Perioperatively
Pathology assesment per SLN
The pathology of the identified SLN during surgery
Time frame: Perioperatively
Detection time
Time in minutes to excise the SLN, measured from start of SLN procedure until detection of the first SLN.
Time frame: Intraoperatively
Complications
Complications including (wound)infection, bleeding, seroma, and mild allergic reaction.
Time frame: From the time of the SLN procedure up until three weeks of follow-up.
Adverse events
Number of adverse events attributable to technetium or ICG.
Time frame: Monitored during study period until one year of follow-up
Locoregional recurrence at 1 year follow-up
Time frame: Until the end of the study (after 1 year of follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
During this phase, surgeons will use ICG as a singe tracer to identify the SLN.
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
...and 1 more locations
Surgeon's expectations regarding ICG
Expectations of the participating surgeons regarding the use of ICG for SLN procedure using a study-specific survey with open-ended questions and multiple choice items.
Time frame: Pre-implementation (prior to the transion phase)
Surgeons' experiences regarding ICG
Experiences of the participating surgeons regarding the use of ICG for SLN procedure using a study-specific survey with open-ended questions and multiple choice items.
Time frame: Up to 12 months after transition to ICG as single tracer
Learning curve per surgeon
The learning curve process will be expressed by visualizing inter-surgeon variability in the number of procedures required to achieve proficiency portrayed in a scatterplot.
Time frame: From each surgeon's first procedure using the double tracer method (technetium and ICG) through completion of the transition phase, assessed over up to 12 months.