Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an implementation study that guides hospitals in adopting peroperative real-time fluorescence imaging with indocyanine green (ICG) for sentinel lymph node biopsy, using the Effective Implementation of Change model by Grol and Wensing. Eligible adult patients with biopsy-confirmed DCIS or invasive breast cancer and a clinically node-negative axilla undergo SLNB with ICG-guided fluorescence rather than the standard 99mTc radioisotope procedure. The trial aims to identify barriers and facilitators to routine use, track implementation outcomes across participating Dutch hospitals, and provide practical guidance to support wider adoption. Data collection includes procedural success, workflow changes, and stakeholder feedback to inform sustainable practice change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Combined MARI procedure
* Known allergy for Indocyanine Green (ICG), intravenous contrast or iodine
* History of axillary lymph node dissection
* Hyperthyroidism or thyroid cancer
* Pregnancy or breast-feeding
* No written informed consent according to ICH/GCP and national regulations.

Where it's running

• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Ziekenhuisgroep Twente
  Hengelo, Netherlands Recruiting
• Spaarne Gasthuis
  Hoofddorp, Netherlands Recruiting
• Dijklander Ziekenhuis
  Hoorn, Netherlands Recruiting
• Alrijne Hospital
  Leiden, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Netherlands Recruiting

Study contacts

• Principal investigator: Annemiek Doeksen, MD, PhD — St. Antonius Hospital
• Study coordinator: Isabelle Henskens, MD
• Email: i.henskens@antoniusziekenhuis.nl
• Phone: +31883202902

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.