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

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520426-11-00

Acronym

RH-FG001-001

Enrollment

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma, Meningioma

Brief summary

Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.

Detailed description

Efficacy (Demonstrate exposure of FG001), Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)

Interventions

DRUGFG001

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.	—

Secondary

Measure	Time frame
Efficacy (Demonstrate exposure of FG001), Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026