Clinical trial · Interventional
Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer
Implementation of Fluorescence Imaging Using Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fluorescence Imaging | — | UNRESOLVED | — |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Lymph Node Mapping | — | UNRESOLVED | — |
| Radioisotopes | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
| Sentinel Lymph Node Detection | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
| Sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| Technetium (99mTc) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Pre-implementation (99mTc only)
- description
- 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.
- interventionNames
- Drug: Technetium (99mTc)
- Drug: Indocyanine Green
- Procedure: Sentinel lymph node biopsy
- type
- EXPERIMENTAL
- label
- Transition phase (99mTc + ICG)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHenskens IJ, Dinger TL, Stekelenburg I, Dijksman LM, Verkooijen HM, Postma EL, Doeksen A, Schuijt HJ; INFINITE Study Group. Fluorescence imaging using indocyanine green to identify sentinel lymph nodes during surgery for breast cancer (INFINITE): protocol for a hybrid effectiveness-implementation trial using a stepped-wedge cluster design. BMJ Open. 2026 Jun 24;16(6):e117847. doi: 10.1136/bmjopen-2026-117847. PMID 42342397