Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Current imaging devices usually detect cancer prior to surgery. However, these devices cannot
be used during the surgical procedure to visualize lymph nodes with cancer (called "sentinel
lymph nodes"). This is a Phase II study, containing a total of 67 patients with head and neck
cancer. The purpose of this study is to test if imaging, with cRGDY-PEG-Cy5.5-C dots is
useful for evaluating your type of cancer. This is currently not approved by the FDA. The
researchers want to see if cRGDY-PEG-Cy5.5-C dots, can improve upon the usual scans. As a
part of your standard of care, you will initially undergo imaging of your lymph nodes prior
to your surgery. Prior to your surgery, you will be injected with a radioactive dye around
the tumor site, and images will be acquired about 2 hours later using a device to image the
location of the dye. We have tested, for the first time in humans, a new, experimental
dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This particle,
the size of a small protein, will be injected around sites of your tumor before or during
your surgery to identify diseased nodes using a hand-held camera system. The dye-labeled
particle can be viewed in tissues that may contain tumor. The particles will not treat your
cancer and any images or information found during this study will not be used for your
treatment. The information collected may be used to guide the design of future studies to
detect and/or treat tumors.