Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer

Summary

The goal of this clinical trial is to learn how to successfully introduce a new method for finding the sentinel lymph node during breast cancer surgery into routine hospital care. The method uses a dye called indocyanine green (ICG) and a special camera to see the lymph node. The sentinel lymph node is the first lymph node that cancer is likely to spread to.

In the Netherlands, about 1 in 7 women develops breast cancer. Finding out whether cancer has spread to the lymph nodes is important for planning treatment and predicting outcomes. The current standard method for sentinel lymph node biopsy (SLNB) uses a radioactive tracer called radioisotope technetium-labeled (99mTc)-nanocolloid. While accurate, this method has several drawbacks: it exposes patients to radioactivity, requires an extra hospital visit or travel to another hospital due to limited nuclear medicine facilities, and is not sustainable. Surgeries using 99mTc can only take place on certain days due to logistical issues, and the signal from 99mTc can be disturbed by the tumor marker placed in the breast.

ICG works as well as 99mTc for SLNB and offers several advantages: it is given during surgery (no extra visit needed), produces no radiation, and reduces costs. However, it is still not widely used in the Netherlands because hospitals may not be familiar with it or unsure how to make the switch.

This study will introduce ICG step-by-step in several Dutch hospitals and evaluate how to make the change as smooth and effective as possible. It will take place in three stages: I) SLNB with 99mTc only (current practice); II) SLNB with both 99mTc and ICG (transition phase); III) SLNB with ICG only (full implementation).

All study procedures take place during planned surgery, with no extra hospital visits. After surgery, participants will receive a short questionnaire (10-15 minutes) to share their experiences with the procedure. Their feedback, combined with input from healthcare providers, will help researchers develop a uniform medical protocol, an implementation guide, and educational materials for surgeons and surgical trainees.

The aim is to make ICG widely available across the Netherlands, ensuring that care is less burdensome, more sustainable, and more cost-effective, while keeping treatment accessible in local hospitals.

Conditions

• Breast Cancer
• Sentinel Lymph Node Biopsy (SLNB)
• Sentinel Lymph Node Detection
• Sentinel Lymph Node
• Lymphatic Metastasis
• Fluorescence Imaging
• Indocyanine Green (ICG)
• Radioisotopes
• Lymph Node Mapping

Interventions

DRUG

Technetium (99mTc)

A radiopharmaceutical tracer consisting of technetium-99m (99mTc)-labelled nanocolloid used for sentinel lymph node mapping. In this study, 99mTc-nanocolloid is administered via periareolar injection with an activity of 40 MBq for the one-day protocol or 100 MBq for the two-day protocol, according to local hospital practice. Injection is performed either on the day of surgery or the afternoon before surgery. Preoperative lymphoscintigraphy is carried out to visualize lymphatic drainage. During surgery, a gamma-detection probe is used to locate and remove the sentinel lymph node(s) identified by 99mTc uptake.

DRUG

Indocyanine Green

Indocyanine Green (ICG) is a fluorescent dye used for intraoperative sentinel lymph node mapping. In this study, a total dose of 5 mg (2 mL) of ICG is administered via periareolar injection after induction of general anesthesia and prior to axillary incision. During surgery, near-infrared fluorescence imaging is used to visualize lymphatic drainage and identify the sentinel lymph node(s). The identified node(s) are surgically removed under fluorescence guidance. In the transition phase, fluorescence findings are cross-checked against 99mTc uptake to ensure accuracy and safety.

PROCEDURE

Sentinel lymph node biopsy

Sentinel lymph node biopsy (SLNB) is a surgical procedure used to identify and remove the first lymph node(s) that drain lymph from a tumor area. In this study, SLNB is performed through a small axillary incision after mapping the sentinel lymph node(s) using either radioisotope technetium-labeled (99mTc)-nanocolloid, indocyanine green (ICG) fluorescence imaging, or a combination of both. The identified lymph node(s) are excised and sent for pathological examination to determine the presence of cancer cells. The procedure is carried out under general anesthesia as part of breast cancer surgery.

Sponsors & Collaborators

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Noordwest Ziekenhuisgroep

  collaborator OTHER

• Alrijne Hospital

  collaborator OTHER

• Dijklander Ziekenhuis

  collaborator OTHER

• Ziekenhuisgroep Twente

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Isabelle Henskens

  lead OTHER

Principal Investigators

• Annemiek Doeksen, MD, PhD · St. Antonius Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-18

Primary Completion

2026-07-31

Completion

2026-08-31

Countries

• Netherlands

Study Locations