Breast Cancer
Conditions
Keywords
indocyanine green, fluorescence, sentinel lymph node biopsy, sentinel lymph node mapping, sentinel lymph node procedure, ICG, implementation
Brief 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.
Detailed description
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.
Interventions
PROCEDUREPhase 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.
PROCEDUREPhase 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.
PROCEDUREPhase 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.
Sponsors
St. Antonius Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identifaction rate | Perioperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of SLNs identified per tracer | Perioperatively | Percentage of SLNs that had technetium uptake / were fluorescent. |
| Pathology assesment per SLN | Perioperatively | The pathology of the identified SLN during surgery |
| Detection time | Intraoperatively | Time in minutes to excise the SLN, measured from start of SLN procedure until detection of the first SLN. |
| Complications | From the time of the SLN procedure up until three weeks of follow-up. | Complications including (wound)infection, bleeding, seroma, and mild allergic reaction. |
| Number of lymph nodes identified | Perioperatively | This indicates the total number of lymph nodes identified with ICG or technetium. |
| Locoregional recurrence at 1 year follow-up | Until the end of the study (after 1 year of follow-up) | — |
| Surgeon's expectations regarding ICG | Pre-implementation (prior to the transion phase) | 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. |
| Surgeons' experiences regarding ICG | Up to 12 months after transition to ICG as single tracer | 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. |
| Learning curve per surgeon | 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. | 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. |
| Adverse events | Monitored during study period until one year of follow-up | Number of adverse events attributable to technetium or ICG. |
Countries
Italy, Netherlands
Outcome results
None listed