Phase 2 FG001 uPAR-targeted near-infrared fluorescent imaging agent for high-grade glioma surgery.

This prospective, single-group, open-label Phase 2 study tests whether FluoGuide A/S’s FG001 can improve intraoperative visualization of malignant tissue during first surgery for newly diagnosed high-grade glioma. FG001 is a urokinase-type plasminogen activator receptor (uPAR)–targeted near-infrared (NIR) fluorescent imaging agent (a targeted dye) given as a single intravenous dose (0.45 mg/kg) about 12–19 hours before tumor resection, then surgeons use NIR fluorescence guidance during resection. The primary performance readout is tumor-to-background fluorescence ratio comparing tumor bulk vs adjacent normal tissue; a key clinical utility endpoint is early (≤48 hours) postoperative MRI–based extent of resection using RANO resect classes (complete/near-total vs submaximal residual). Eligible histologies include glioblastoma (IDH-wildtype), astrocytoma (IDH-mutant), and oligodendroglioma (IDH-mutant, 1p/19q-codeleted) confirmed intra- or postoperatively. The commercial/scientific angle is a potential “registration-style” imaging study aiming to standardize fluorescence-guided neurosurgery beyond today’s approach of maximal safe resection under white light ± 5-ALA fluorescence, followed by radiation plus temozolomide for glioblastoma and tailored adjuvant therapy for other grade 3–4 gliomas. Miami, FL; Pittsburgh, PA; Galveston, TX; Salt Lake City, UT; plus Lebanon | NCT07609472