(Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with supratentorial brain tumors (EudraCT-No.: 2014-005669-54))

Beteiligte Wissenschaftler*innen:
Akad. Oberrat Dr. Dipl.-Stat. J. Gerß
Dr. rer. nat. Jeanette Köppe
Dr. rer. physiol Veronika Weyer-Elberich

Studienleitung:
Univ.-Prof. Dr. med. Walter Stummer

The 5-ALA study is a prospective, open-label, single-arm, multinational, multicenter phase II trial investigating the use of 5-aminolevulinic acid (5-ALA) in children and young adolescents with intra-axial brain tumors. The primary objective is to assess safety, defined as the frequency of grade III–V adverse events according to Common Terminology Criteria (CTC), in the context of fluorescence-guided tumor resection. 
The study uses an adaptive two-stage design, with statistical evaluation based on an adaptive inverse normal method.