Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors

Summary

In this prospective, open, single-armed, multicenter, phase II study for application of 5-ALA in children and adolescents with brain tumors 80 patients will be investigated. Primary objective of the study is to determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with intra-axial brain tumors. Secondary objectives are * to determine whether fluorescent tissue truly signifies tumor (positive predictive value) in various pediatric brain tumors * to determine the degree of tumor resection on early post-operative MRI * and to determine the pharmacokinetics of 5-ALA in this population.

Timeline

Start

2020-09-25

Primary completion

2025-11-24

Completion

2025-11-24

Drugs

Indications