FluoGuide has submitted a clinical trial application to the Danish Medicines Agency for a planned phase II trial of its intraoperative technology for head and neck cancer.
The trial aims to obtain proof-of-concept in head and neck cancer for the company's uPAR platform technology used to guide surgical removal of cancer. The plan is to enroll up to 16 patients. The goal is improving sensitivity defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology.
FluoGuide said that upon approval, it will begin the trial in collaboration with University Hospital, Rigshospitalet, in Denmark. The principal investigator is Dr. Anders Christensen, PhD.
