NCT04305470

Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: NX Development Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.

Detailed description

This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The exogenous application of ALA leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (λ = 375 - 440 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light. This phenomenon allows for the real-time visualization of tumor tissue during resection surgery. Patients about to undergo resection for suspected meningioma \[World Health Organization (WHO) Grade I, II, III\] will be screened and informed consent will be obtained prior to surgery and prior to study participation. Eligible study participants will receive an oral solution of Gleolan (20 mg/kg body weight) 3 hours, (target range 2-4 hours) prior to anesthesia, and then undergo surgery for meningioma resection. During the surgery, the surgeon will use a microscope equipped with WL and BL for visualization of Gleolan-induced PpIX fluorescence for the selection of protocol-driven tissue locations and to assess fluorescence status. Study participants will be evaluated within 48 hours post procedure, 2 weeks post procedure, and 6 weeks post procedure for study safety assessment.

Conditions

• Meningioma

Interventions

Type	Name	Description
DRUG	Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)	One time oral dose on day of surgery (20 mg/kg bodyweight)

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-11-07
• Completion: 2022-12-13
• First posted: 2020-03-12
• Last updated: 2024-06-18

Locations

17 sites across 3 countries: United States, Austria, Germany

Regulatory

• FDA-regulated drug study