NCT06678867

The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours

A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour. Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
DRUG	5-ALA (Gliolan)	Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2024-11-07
• Last updated: 2025-03-27

Locations

1 site across 1 country: United Kingdom