Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery
Implementation of Fluorescent Imaging Using Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer
This project tests whether indocyanine green dye and a fluorescence camera can be used instead of the radioactive tracer to find sentinel lymph nodes in adults having breast cancer surgery who are clinically node-negative.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1760 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Alkmaar and 6 other locations) |
| Trial ID | NCT07146295 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with biopsy-confirmed DCIS or invasive breast cancer who are clinically node-negative by preoperative axillary ultrasound and are scheduled for breast surgery with an axillary sentinel lymph node procedure are ideal candidates.
Not a fit: Patients with a known allergy to ICG, intravenous contrast or iodine, pregnant or breastfeeding patients, those with prior axillary lymph node dissection, hyperthyroidism or thyroid cancer, or those undergoing combined MARI procedures are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could spare patients exposure to radioactivity, reduce extra hospital visits, simplify scheduling, and make sentinel node detection more sustainable and convenient.
How similar studies have performed: Clinical studies have already shown ICG-fluorescence to be an effective and safe alternative to 99mTc for sentinel node detection, but widespread practical adoption has been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alkmaar and 6 other locations
- 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)
- Diakonessenhuis — Utrecht, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.