Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Phase I: Technetium is administered as single tracer to identify the SLN (current standard).: During this phase, surgeons will use technetium to identify the SLN as this is the current standard of care. This phase will serve as a control group.

Phase II: SLN biopsy using double tracer technetium and ICG (learning curve): During this phase, surgeons will primarily use ICG to identify the sentinel lymph node (SLN), while technetium will serve as a control. This approach allows surgeons to gain proficiency with ICG-guided SLN biopsy and safely advance through the learning curve.

Phase III: ICG is administered as single tracer to identify the SLN (alternative method).: During this phase, surgeons will use ICG as a singe tracer to identify the SLN.

Study summary

This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and potential side effects. Extensive research indicates that Indocyanine Green (ICG) is an equally effective and potentially more practical alternative. Conducting this study will help accelerate the implementation of ICG in clinical practice.

Eligibility

Primary outcome measure(s)

• Identifaction rate — Perioperatively
  Identification rate is defined as the proportion of patients in whom lymph nodes were identified with the gamma-probe using technetium or the fluorescent signal of ICG.

Trial sites (11)

Other trials for the same condition