Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

Phase 3 Completed 108 enrolled NX Development Corp

NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start: 2020-10-28
Primary completion: 2022-11-07
Completion: 2022-12-13

Outcome

Met primary endpoint

registry NUMBER Intent to Image Analysis Population: 60.2 (50.76 to 68.91) Percentage of Participants NCT04305470 ↗

registry analysis (other test); Intent to Image Analysis Population; p <0.0001; Wilson's method through the Wald Test NCT04305470 ↗

release “phase 3 study (MEN-301) and comfortably met the primary endpoint, investigating 5-ALA as an adjunct in meningioma patients” photonamic.de ↗

Publications

Results Stummer W, Holling M, Bendok BR, Vogelbaum MA, Cox A, Renfrow SL, Widhalm G, Ezrin A, DeSena S, Sackman ML, Wyse JW. The NXDC-MEN-301 Study on 5-ALA for Meningiomas Surgery: An Innovative Study Design for the Assessing the Benefit of Intra-Operative Fluorescence Imaging. Brain Sci. 2022 Aug 6;12(8):1044. doi: 10.3390/brainsci12081044.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminolevulinic Acid	Diagnostic / imaging agent	20 mg/kg	Oral