OncoMatch/Clinical Trials/NCT06684795
FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery
Is NCT06684795 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FG001 prior to surgery for low-grade glioma.
Treatment: FG001 prior to surgery — In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Cannot have received: FG001 (FG001)
Subject must not previously have received the trial drug (FG001)
Lab requirements
Blood counts
Subjects must have normal bone marrow function
Kidney function
No pre-existing renal insufficiency; eGFR below 45 ml/min/1.73m2 excluded
Liver function
No pre-existing hepatic insufficiency; INR above 1.7 excluded
Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care; Pre-existing hepatic and/or renal insufficiency (INR above 1.7, eGFR below 45 ml/min/1.73m2) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify