Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer

A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.

Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection

Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection

Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection

Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection

Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection

Inclusion Criteria: Early stage breast cancer (T1, T2) Clinically node negative (no enlarged axillary lymph nodes) Exclusion Criteria: Prior surgery in same breast Pregnancy or breastfeeding

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