Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

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

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

Indications