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

NCT07311278 | Active Not Recruiting

• 1 other identifier: NL79223.100.22
• Study Type: interventional
• Target: 493
• Locations: 2 countries
• Sites: 11

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.

Conditions

Breast Cancer

Keywords

indocyanine green; fluorescence; sentinel lymph node biopsy; sentinel lymph node mapping; sentinel lymph node procedure; ICG; implementation

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperatively

Secondary Outcomes (10)

• Number of lymph nodes identified

  Perioperatively

• Percentage of SLNs identified per tracer

  Perioperatively

• Pathology assesment per SLN

  Perioperatively

• Detection time

  Intraoperatively

• Complications

  From the time of the SLN procedure up until three weeks of follow-up.

Study Arms (3)

Phase I: pre-implemtation phase

OTHER

SLN biopsy using single tracer techentium (current standard)

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

Phase II: transition phase

OTHER

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

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

Phase III: post-implementation phase

OTHER

SLN biopsy using single tracer ICG (alternative method)

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

Interventions

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

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.

Phase I: pre-implemtation phase

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

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.

Phase II: transition phase

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

During this phase, surgeons will use ICG as a singe tracer to identify the SLN.

Phase III: post-implementation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (11)

Ospedale Pederzoli

Peschiera del Garda, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

FlevoZiekenhuis

Almere Stad, Netherlands

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Van Weel-Bethesda Ziekenhuis

Dirksland, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

HagaZiekenhuis

The Hague, Netherlands

Location

Bernhoven Ziekenhuis

Uden, Netherlands

Location

Isala Ziekenhuis

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 30, 2025
• Study Start: June 8, 2023
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-11

Locations

NL (10); IT (1)