NCT04738162View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 25, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Brain Tumor, Pediatric
Interventions
DRUG

5-Aminolevulinic Acid Hydrochloride, Oral

Application of 5-ALA oral solution (20mg/kg bw) 4 hours (range 3.5-4.5 hours) prior to anesthesia followed by fluorescence-guided tumor resection Tumor resection is performed conventionally using a surgical microscope. A change from white light to blue light is possible at anytime to make the fluorescence visible

Trial Locations (7)

3584

RECRUITING

Prinses Máxima Centrum voor kinderoncologie BV, Utrecht

45147

RECRUITING

Universitätsklinikum Essen, Klinik für Neurochirurgie, Essen

48149

RECRUITING

University Hospital Münster, Klinik für Neurochirurgie, Münster

55131

RECRUITING

Universitätsmedizin Mainz, Klinik und Poliklinik für Neurochirurgie, Mainz

72076

RECRUITING

Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Tübingen

81377

RECRUITING

Neurochirurgische Klinik der Universität München (LMU), München

86146

RECRUITING

Universitätsklinikum Augsburg, Klinik für Neurochirurgie, Augsburg

All Listed Sponsors
collaborator

photonamic GmbH & Co. KG

INDUSTRY

collaborator

medac GmbH

INDUSTRY

lead

Universität Münster

OTHER