NCT07311278

Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients

Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 493 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-10-30
• Completion: 2026-10-01
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

11 sites across 2 countries: Italy, Netherlands