Introducing Indocyanine Green Fluorescence Imaging to Find Sentinel Lymph Nodes During Breast Cancer Surgery in Dutch Hospitals

What this Trial Is About

Breast cancer affects about one in seven women, and determining if cancer has spread to the lymph nodes is vital for treatment planning and predicting outcomes. This trial evaluates a new method using indocyanine green ICG fluorescence imaging to identify the sentinel lymph node during breast cancer surgery. The study aims to introduce ICG into regular hospital care in the Netherlands, comparing it to the current standard method using a radioactive tracer, technetium-labeled 99mTc-nanocolloid, which has logistical challenges and exposes patients to radiation. The trial is conducted in three phases first, using the standard 99mTc method second, a transition phase combining both 99mTc and ICG and third, fully implementing ICG alone. During surgery, ICG is injected after anesthesia and visualized with a special camera to locate lymph nodes, while 99mTc requires preoperative injection and imaging. The study takes place in several hospitals and involves gradually introducing ICG while monitoring and adjusting the process. Participants undergo sentinel lymph node biopsy during planned surgery with no extra hospital visits. After surgery, they complete a short questionnaire about their experience. Researchers collect data on how well ICG is adopted, patient satisfaction, procedure safety, costs, and surgical outcomes. The trial aims to create medical protocols and educational materials to support widespread, sustainable use of ICG in breast cancer care.

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