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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥ 18 years old.

• DCIS or invasive breast cancer, confirmed by biopsy

• Clinically node-negative, confirmed by preoperative axillary ultrasound

• Indication for breast cancer surgery with SLN procedure via axillar incision

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Ziekenhuisgroep Twente
RECRUITING
Hengelo
Spaarne Gasthuis
RECRUITING
Hoofddorp
Dijklander Ziekenhuis
RECRUITING
Hoorn
Alrijne Hospital
RECRUITING
Leiden
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Diakonessenhuis
RECRUITING
Utrecht
Contact Information
Primary
Isabelle Henskens, MD
i.henskens@antoniusziekenhuis.nl
+31883202902
Backup
Annemiek Doeksen, MD, PhD
a.doeksen@antoniusziekenhuis.nl
+3188 320 29 00.
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2026-08
Participants
Target number of participants: 1760
Treatments
Active_comparator: Pre-implementation (99mTc only)
Participants undergo sentinel lymph node biopsy (SLNB) using the current standard of care: injection of radioisotope technetium-labeled (99mTc)-nanocolloid and preoperative lymphoscintigraphy, followed by radio-guided surgery with a gamma-detection probe.
Experimental: Transition phase (99mTc + ICG)
Participants receive preoperative injection of radioisotope technetium-labeled (99mTc)-nanocolloid and preoperative lymphoscintigraphy (without marking the location on the skin). Surgeons are blinded to preoperative lymphoscintigraphy results. After induction of general anesthesia, indocyanine green (ICG) is injected periareolar. Surgery is primarily guided by ICG fluorescence imaging to identify and remove the sentinel lymph node(s). Excised lymph nodes are then checked for 99mTc activity using a gamma-detection probe as a control. This phase is designed to allow surgeons to gain experience with the ICG technique while maintaining safety through parallel use of the established 99mTc method.
Active_comparator: Post-implementation (ICG only)
Participants undergo SLNB using ICG only. ICG is injected periareolar after induction of general anesthesia and visualized intraoperatively with a fluorescence camera to guide excision of the sentinel lymph node(s).
Related Therapeutic Areas
Sponsors
Collaborators: Spaarne Gasthuis, Dijklander Ziekenhuis, Noordwest Ziekenhuisgroep, Alrijne Hospital, Canisius-Wilhelmina Hospital, Diakonessenhuis, Utrecht, ZonMw: The Netherlands Organisation for Health Research and Development, Ziekenhuisgroep Twente
Leads: Isabelle Henskens

This content was sourced from clinicaltrials.gov