NCT06684795

FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

An Open-label, Non-randomized, Single Dose, Phase II Trial of FG001 (an Optical Imaging Agent) for Localization of Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The drug FG001 (ICG-Glu-Glu-AE105), a uPAR-targeting fluorescent drug, has been tested in patients with high-grade glioma as part of a First-in-human clinical trial and demonstrated an excellent safety profile and efficacy results. Animal studies have indicated uptake of FG001 in low-grade glioma while uptake has been shown in one clinical case of meningioma providing the basis for this trial. Consequently, the investigators intend to test the ability of FG001 to reliably fluoresce in patients with presumed low-grade glioma or meningioma.

Conditions

• Low-grade Glioma
• Meningioma
• Glioma

Interventions

Type	Name	Description
DRUG	FG001 prior to surgery	Patients will receive a single intravenous injection of 36 mg FG001 administered the day before surgery.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: Denmark