Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Supratentorial Brain Tumors
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
In this prospective, open, single-armed, multicenter, phase II study for application of 5-ALA
in children and adolescents with supratentorial 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 supratentorial, 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.