Evaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van de schildwachtklier bij patienten met borstkanker.

Rationale:

This project consists on the clinical validation of an imaging modality dedicated to sentinel lymph nodes identification and localization in the case of breast cancer. An intra-operative near-infrared fluorescence imaging camera will be evaluated for its ability to detect the sentinel lymph node (SLN) in patients with breast cancer compared to the standard procedure in a non-inferiority study design. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The end-goal is to significantly improve the detection and efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity in future studies on near-infrared tumor-targeted optical contrast agents.

This non-inferiority study specifies as a null hypothesis that ICG enhanced NIRF imaging is inferior in detecting sentinel lymph nodes compared to the current standard treatment (technetium-99m combined with Patent Blue).

Day of surgery.

Patients with operable breast cancer stage I-II undergoing a lumpectomy, combined with a sentinel lymph node procedure, will receive prior to a lumpectomy and SLN procedure an intratumoral injection with indocyanin green (ICG).
During the operative procedure NIRF imaging for detection of the SLN (i.e. ICG accumulation) will take place.