Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
Status:
Withdrawn
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
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.