MedTrace Logo

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

NCT04738162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-12-10

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • photonamic GmbH & Co. KG

    collaborator INDUSTRY

  • medac GmbH

    collaborator INDUSTRY

  • Universität Münster

    lead OTHER

Principal Investigators

  • Walter Stummer, Prof. · University Hospital Muenster

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2025-11-24
Completion
2025-11-24

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738162 on ClinicalTrials.gov