Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients (INFLUENCE II)

St. Antonius Hospital

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Phase III: ICG is administered as single tracer to identify the SLN (alternative method).; Procedure: Phase II: SLN biopsy using double tracer technetium and ICG (learning curve); Procedure: Phase I: Technetium is administered as single tracer to identify the SLN (current standard).

Study type: Interventional

Funder types: Other

Identifiers

NCT07311278

NL79223.100.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 493 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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493 participants in 3 patient groups

Phase I: pre-implemtation phase

Other group

Description:

SLN biopsy using single tracer techentium (current standard)

Treatment:

Procedure: Phase I: Technetium is administered as single tracer to identify the SLN (current standard).

Phase II: transition phase

Other group

Description:

SLN biopsy using double tracer technetium and ICG (learning curve)

Treatment:

Procedure: Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)

Phase III: post-implementation phase

Other group

Description:

SLN biopsy using single tracer ICG (alternative method)

Treatment:

Procedure: Phase III: ICG is administered as single tracer to identify the SLN (alternative method).