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Brief Title: Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Supratentorial Brain Tumors
Official Title: Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Supratentorial Brain Tumors
Study ID: NCT04738162
Brief 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.
Detailed Description: In 2007, 5-aminolevulinic acid (5-ALA) was approved in Europe by the European Medicines Agency (EMA) (brand name: Gliolan®) for "the visualization of malignant tissue during surgery for malignant glioma (WHO III and IV) in adults." Similarly, approval for 5-ALA was granted by the FDA in 2017 as an "optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery" (brand name: Gliolan®). Goal of the study is to investigate if the use of 5-ALA is safe in children and get preliminary information on the type of paediatric brain tumors which are suitable for fluorescence-guided resection with 5-ALA.
Minimum Age: 3 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Augsburg, Klinik für Neurochirurgie, Augsburg, , Germany
Universitätsklinikum Essen, Klinik für Neurochirurgie, Essen, , Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurochirurgie, Mainz, , Germany
Neurochirurgische Klinik der Universität München (LMU), München, , Germany
University Hospital Münster, Klinik für Neurochirurgie, Münster, , Germany
Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Tübingen, , Germany
Prinses Máxima Centrum voor kinderoncologie BV, Utrecht, , Netherlands
Name: Walter Stummer, Prof.
Affiliation: University Hospital Muenster
Role: PRINCIPAL_INVESTIGATOR