Trial intelligence / Profile preview

FG001 for Localization of Meningiomas or Low-Grade Gliomas

NCT06684795Phase 2

Key facts

Status
Recruiting
Start
May 2024
Primary completion
Jun 2026
Countries
1
Sponsor
Rigshospitalet
Modality
Light/Condition-Responsive Prodrugs
Drugs
FG001
Conditions
meningiomaglioma
01

Overview

Phase 2, open-label trial of FG001 in meningioma and glioma (2 arms), sponsored by Rigshospitalet. Primary endpoint: Sensitivity for detection of tumor tissue at 24 months. Started May 2024; status: recruiting.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Presumed low-grade glioma

    Patients with presumed low-grade glioma receiving FG001 prior to surgery

  • Meningioma

    Patients with meningioma receiving FG001 prior to surgery

03

Who it enrols

Adult patients with MRI suggestive of meningioma or presumed low-grade glioma scheduled for neurosurgery, with normal organ function and no allergy to ICG.

04

Endpoints

Primary

  • Sensitivity for detection of tumor tissue

Secondary

  • Specificity for detection of tumor tissue

  • Tumor-to-Background Ratio

  • Incidence of Adverse Events

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