​FG001 in the visualisation of malignant gliomas. This trial is designed as a first in human, open-label, non-randomized, dose escalation, single-dose administration, multi-center phase I/II clinical trial aiming to investigate a new uPAR-targeting optical probe for targeted intraoperative visualization of malignant glioma in patients scheduled for neurosurgery.  The objective of the initial phase 1 is to evaluate the safety and tolerability of single intravenous doses of FG001 as well as establish the optimal imaging dose of FG001 in patients suspected of malignant gliomas planned for neurosurgery. FG001 is a novel fluorescent compound that binds specifically to the human urokinase-type plasminogen activator receptor (uPAR). uPAR has been shown to be overexpressed in most solid cancers, especially glioblastoma and facilitates the invasion of the cancer cells into normal tissue. Thus, uPAR is an ideal target for tumor-specific fluorescence-guided neurosurgery with a high potential for aiding the neurosurgeons in the delineation between tumor and normal tissue during surgery. The study is currently ongoing with 31 enrolled patients in phase 1 with a maximum investigated dose of 36 mg and so far no drug related adverse events. An international multicenter phase 2 study is already under way aiming to evaluate the efficacy of FG001 in  patients suspected for malignant gliomas planned for neurosurgery. 

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