NCT Number: NCT07311278
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ospedale Pederzoli, Peschiera del Garda, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
During this phase, surgeons will use ICG as a singe tracer to identify the SLN.
Time frame: 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.
Time frame: Perioperatively
This indicates the total number of lymph nodes identified with ICG or technetium.
Time frame: Perioperatively
Percentage of SLNs that had technetium uptake / were fluorescent.
Time frame: Perioperatively
The pathology of the identified SLN during surgery
Time frame: Intraoperatively
Time in minutes to excise the SLN, measured from start of SLN procedure until detection of the first SLN.
Time frame: From the time of the SLN procedure up until three weeks of follow-up.
Complications including (wound)infection, bleeding, seroma, and mild allergic reaction.
Time frame: Monitored during study period until one year of follow-up
Number of adverse events attributable to technetium or ICG.
Time frame: Until the end of the study (after 1 year of follow-up)
Time frame: 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.
Time frame: 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.
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.
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.
St. Antonius Hospital
Other
Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.
Acronym: INFLUENCE II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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