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

What this Trial Is About

Researchers are evaluating a new method to find the sentinel lymph node during breast cancer surgery using a dye called indocyanine green (ICG) combined with a special camera. This method is being studied to replace the current standard that uses a radioactive tracer called technetium-labeled (99mTc) nanocolloid, which requires extra hospital visits and exposes patients to radiation. The trial aims to introduce ICG in several Dutch hospitals and assess how to best implement this change in routine care to make the process less burdensome, more sustainable, and cost-effective. The study is organized in three phases: first, using the standard 99mTc method alone; second, a transition phase where both 99mTc and ICG are used together; and third, full implementation using ICG only. During surgery, ICG is injected after anesthesia and visualized with fluorescence imaging to guide removal of the sentinel lymph node. The trial takes place during planned breast cancer surgery with no extra hospital visits required for participants. Participants will be monitored through surgical procedure data and a short questionnaire about their experience sent within a week after surgery. Researchers will also gather feedback from healthcare providers to develop a standard medical protocol, educational materials, and an implementation guide. The main outcome measured is how often ICG is adopted during the final phase, along with safety, patient satisfaction, cost, and effectiveness of the new method. The study is expected to continue until August 2026.

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